[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iron-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iron-deficiency":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,47,78,100,131,173,212,235,266,292,316,347,368,400,427,456,481,512,552,576,607,634,657,691],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100623242","assessing-clinical-impact-of-ai-for-iron-deficiency-100623242",false,"NCT07394088","Assessing Clinical Impact of AI for Iron Deficiency","Evaluation of the Clinical Impact of Machine Learning-Based Risk Classification Using Blood Analysis on Iron Deficiency Detection","Inclusion Criteria:\n\n1. Adults aged 18 years or older.\n2. Patients attending outpatient clinics of participating departments including 2.1. Internal Medicine, 2.2 Family Medicine 2.3. Hematology\u002FOncology\n3. Completion of a routine complete blood count (CBC) as part of usual clinical care during the outpatient encounter.\n4. Availability of the CBC report in the institutional laboratory information system, allowing sufficient data for analysis.\n\nExclusion Criteria:\n\n1. Encounters with missing or incomplete key identifiers (e.g., patient identification number, ) that prevent determination of exposure status (AI information displayed vs not displayed) or assessment of outcomes within the defined follow-up period.\n2. Encounters without a valid department code required by the information system to trigger the randomization mechanism and AI risk display.\n3. Encounters with incomplete or missing laboratory data required to activate the AI system.\n4. Repeated CBC encounters from the same patient during the study period, if applicable; only the first eligible encounter will be included to avoid duplication.","ALL","18 Years",{"count":19,"type":20},2196,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate whether an AI-based risk notification system integrated into routine clinical care can improve the clinical detection of iron deficiency in adult patients attending Internal Medicine, Family Medicine, and Hematology\u002FOncology clinics at China Medical University Hospital in Taiwan.\n\nThe main questions this study aims to answer are:\n\n1. Does displaying AI-generated iron deficiency risk classification to physicians increase the overall detection rate of iron deficiency at the population level?\n2. Does the AI-based risk notification influence physicians' diagnostic behavior by increasing the rate at which ferritin testing is ordered specifically for suspected iron deficiency?\n3. Among ferritin tests ordered for suspected iron deficiency, does the diagnostic yield (positivity rate) remain appropriate, reflecting efficient use of testing resources?\n4. Are the effects of the AI-assisted intervention consistent among patients with anemia and without anemia?\n\nComparison Groups Researchers will compare clinical encounters in which physicians receive AI-generated iron deficiency risk information (the Prompt Group) with encounters in which physicians receive standard laboratory results without AI risk display (the Control Group). The comparison focuses on differences in iron deficiency detection, ferritin ordering behavior for suspected iron deficiency, and diagnostic yield.\n\nWhat Participants Will Experience\n\n1. No Additional Procedures:\n\n   As this is a pragmatic study embedded in routine clinical care, participants will not undergo any additional blood draws, invasive procedures, or clinic visits beyond standard care.\n2. Routine Care Only:\n\n   Patients attend their scheduled outpatient visits and receive complete blood count (CBC) testing as ordered by their treating physician, independent of study participation.\n3. Background Data Integration:\n\n   The AI system operates within the hospital's information system, analyzing routinely collected CBC data after results become available. No additional data entry or action is required from patients.\n4. Physician Autonomy Preserved:\n\nThe AI provides a non-mandatory risk classification as decision support. For patients identified as high risk, the system may display an informational prompt suggesting consideration of iron-related testing if no recent testing is found. All diagnostic and management decisions remain entirely at the discretion of the treating physician.",[26,27],"Iron Deficiency","Iron Deficiency Anemias",[29,30,31,32,33],"machine learning","complete blood count","iron deficiency","pragmatic randomized trial","detection rate","RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-26","ACTUAL",{"date":40,"type":38},"2026-04-01",{"date":42,"type":20},"2027-03",{"name":44,"class":45},"China Medical University Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":46},"100465418","phase-2-darbe-plus-iv-iron-to-decrease-transfusions-while-maintaining-iron-sufficiency-in-preterm-infants-100465418","NCT05340465","Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants","Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants","DIVI","Inclusion Criteria:\n\n• NICU patients (male and female) born at 24-0\u002F7 to 31-6\u002F7 weeks of gestation\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Known fetal\u002Finfant anomalies of clinical significance (brain, cardiac, chromosomal anomalies)\n* Parental consent unable to be obtained by 72 hours after birth\n* Central hematocrit \\> 65%\n* Evidence of high iron stores prior to enrollment (e.g. Ferritin \\>400 ng\u002FmL with corresponding ZnPP\u002FH of \\\u003C30, Transferrin saturation \\>75%, iron \\> 200 mcg\u002FdL, TIBC \\\u003C 100 mcg\u002FdL)\n* Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment\n* Mother under 18 years of age\n* Unable to consent in English or Spanish","3 Days",{"count":57,"type":20},120,[59],"PHASE2","In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants.\n\nInvestigators hypothesize that in infants \\\u003C 32 completed weeks of gestation, combined treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran (LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome",[62,63,64,65],"Prematurity","Iron-deficiency","Iron Deficiency Anemia","Iron Malabsorption",[67,31,68,69,70],"prematurity","anemia","darbepoetin","IV Iron",{"date":37,"type":38},{"date":73,"type":38},"2022-11-27",{"date":75,"type":20},"2027-06-30",{"name":77,"class":45},"University of Washington",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":87,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":46},"100486072","imaging-intravenous-iron-100486072","NCT05609318","Imaging Intravenous Iron","Study of Tissue Iron Uptake in Iron-Deficient Patients Receiving Intravenous Iron Replacement Therapy: A Prospective Observational Study (STUDY)","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged 18 years or above.\n* Anaemia (haemoglobin less than 120g\u002FL for women and less than 130g\u002FL for men) and\u002For confirmed iron deficiency (ferritin less than 100mcg\u002FL and\u002For transferrin saturation less than 20%).\n* Scheduled to receive intravenous iron for correction of iron deficiency.\n\nExclusion Criteria:\n\n* Any MRI incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel\u002Fbullets)\n* Pregnant or lactating participant\n* Acute decompensated heart failure\n* Unstable clinical status\n* Any other medical conditions which would influence the reliability of the study results determined by the investigators.\n* Any other contraindication to MRI to be confirmed by the qualified MRI operator, e.g. tattoos containing traces of metal.",{"count":86,"type":20},12,"6 Weeks","OBSERVATIONAL","The aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. We will track iron in tissues using MRI relaxometry parameters R1\u002FR2\u002FR2\\* which are well established as accurate indicators of tissue iron content.",[63],"2026-05-06",{"date":93,"type":38},"2026-05-11",{"date":95,"type":38},"2022-10-29",{"date":97,"type":20},"2026-12-31",{"name":99,"class":45},"University of Oxford",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100517241","efficacy-and-adverse-side-effects-of-two-forms-of-iron-in-pregnancy-100517241","NCT06014983","Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy","Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial","EASE-Iron","Inclusion Criteria:\n\n* Pregnant individual (singleton pregnancy)\n* 19-42 years of age\n* Living in the greater Vancouver area and willing to travel to the University of British Columbia or BC Women's Hospital for study visits\n* 13-25 weeks gestation\n* Willing to participate and able to provide informed consent\n\nExclusion Criteria:\n\n* Having a pre-existing medical condition known to impact iron status (e.g., inherited hemoglobin disorder (i.e., sickle cell, hemochromatosis, thalassemia or other structural hemoglobin variant), malabsorptive disorders (i.e., chronic pancreatitis, cystic fibrosis, celiac disease) and inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), gastric bypass surgery, atrophic gastritis, advanced liver disease, kidney dialysis)\n* Using medications known to interfere with iron metabolism or the gut pathogen equilibrium (e.g., chronic use of proton pump inhibitors, anti-inflammatory agents, non-steroidal anti-inflammatory drugs, antibiotics)\n* Having a personal neural tube defect (NTD) history or a previous NTD pregnancy\n* Receiving ongoing blood transfusions\n* Currently smoking or having smoked in the past 3 months\n* Pre-pregnancy body mass index (BMI) ≥30 kg\u002Fm\\^2\n* Allergy to any study supplement ingredients",true,"FEMALE","19 Years","42 Years",{"count":113,"type":20},172,[23],"This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until \\~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline (13-25 weeks gestation) and follow-up (35-37 weeks gestation) to assess how different forms of iron impact body iron stores. Stool samples will be obtained within 1 week of both baseline and follow-up visits to assess changes in gut microbiome composition. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.",[117,26],"Pregnancy",[119,117,120],"Iron","Nutrition","2026-04-23",{"date":123,"type":38},"2026-04-24",{"date":125,"type":38},"2024-04-12",{"date":127,"type":20},"2027-01",{"name":129,"class":45},"University of British Columbia",2,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":108,"sex":109,"minAge":17,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":46},"100634969","a-pilot-study-to-evaluate-the-ability-of-lactoferrin-to-modulate-iron-homeostasis-and-exercise-performance-in-exercising-females-100634969","NCT07546591","A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females","A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females With Compromised Iron Status","EFF","Inclusion Criteria:\n\n* Women, 18 - 45 years of age\n* No changes in hormonal contraception use in the past 6 months\n* Has a regular menstrual cycle defined as five out of the past six months\n* Engaging in ≥5 hours per week of structured endurance exercise (e.g., running, cycling, swimming, rowing) for the past ≥6 months, with ≥3 sessions per week at moderate-to-vigorous intensity (≥70% HRmax or RPE ≥13).\n* Training must be consistent, with no interruptions \\>2 consecutive weeks in the past 6 months and performed with the purpose of improving performance or preparing for a competition or personal goal.\n* Exhibit some degree of compromised iron status as depicted by serum ferritin levels below 30 ug\u002FL\n* Participation in at least one organized endurance event (e.g., races, competitions, or matches) at the recreational, sub-elite, or elite level, or be actively training for a planned competition within the next 6 months.\n* Generally healthy and free of diseases or disorders that impact functioning of the gastrointestinal system.\n* No recent or acute infection in the past 30 days and no chronic systemic illness\n* No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.\n* If psychiatric medication is used: stable regimen for ≥3 months with no anticipated changes during the study\n* Body mass index (BMI) 18.5 to 32.5 kg\u002Fm2 (Inclusive)\n* Non-smoker\n* Agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to any of the study visits.\n* Willing and able to maintain consistent diet and physical activity habits\n* Participants who become pregnant during the course of the study will be removed from participation\n* Willing and able to provide consent and comply with the protocol\n* Able to read and understand English at the 6th-grade level and sign the informed consent to participate in the study\n\nExclusion Criteria:\n\n* History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis, celiac), gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery\n* Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140\u002F90 mmHg), renal or hepatic impairment\u002Fdisease, Type I or II diabetes, any neurologic disease or disorder that may impact cognition or mood, unstable thyroid disease, chronic inflammatory conditions, immune disorders (such as HIV\u002FAIDS), or any medical condition deemed exclusionary by the Principal Investigator (PI)\n* Acute illness or infection within the past 30 days\n* History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.\n* Recently started taking (within the past 90 days or has had their dosage adjusted in the past 90 days) antihypertensives, hypoglycemic medications, GLP1 agonists of any class or type, stimulatory asthma medications, or any other prescription or over-the-counter medication that confound the outcomes measured in this study\n* Habitual use of anti-inflammatory medications for 30 days prior to providing\n* Current or past diagnosis of bipolar I\u002FII disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, attempt, or self-harm behavior in the past 12 months\n* Initiation, discontinuation, or dose change of any psychotropic medication within the past 3 months, including antidepressants, anxiolytics, antipsychotics, mood stabilizers, stimulants, or sedative-hypnotics\n* Subject has an allergy to any ingredients in the study product\n* Subject has a history of drug or alcohol abuse in the past 12 months\n* Excessive alcohol intake defined as greater than 7 drinks\u002Fweek or binge episodes\n* Any condition or abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.\n* Participating in or has participated in another research study within 30 days prior to the screening visit that could confound outcomes\n* Currently pregnant or lactating","45 Years",{"count":141,"type":20},30,[23],"This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin. Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin \\\u003C35 µg\u002FL will be enrolled in an 8-week intervention. Participants will be stratified by baseline ferritin status and randomized to receive 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily.\n\nPrimary outcomes include changes in ferritin and hematological parameters. Secondary outcomes include VO₂peak, time to exhaustion, and blood lactate responses during standardized treadmill testing.\n\nThis study will determine whether lactoferrin enhances iron homeostasis and improves physiological and performance outcomes in exercising women with low iron stores.",[145,146,26,147],"Iron Deficiencies","Low Ferritin","Exercise Performance of Fit Athletes",[149,150,151,152,153,154,155,156,157,158,159,160,161,162,163],"lactoferrin","effera","iron supplementation","iron metabolism","ferritin","aerobic performance","vo2peak","endurance exercise","time to exhaustion","lactate metabolism","female athletes","exercising females","menstruating women","iron bioavailability","nutritional supplementation","2026-04-22",{"date":166,"type":38},"2026-04-27",{"date":168,"type":20},"2026-04-30",{"date":170,"type":20},"2027-04-30",{"name":172,"class":45},"Lindenwood University",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":108,"sex":109,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":46},"100588500","improving-iron-levels-in-female-endurance-intermittent-and-powerstrength-athletes-aged-16-35-100588500","NCT06942208","Improving Iron Levels in Female Endurance, Intermittent, and Power\u002FStrength Athletes Aged 16-35","Iron Revisited: Alternate-Day Oral Iron Supplementation in Endurance, Intermittent, and Power\u002FStrength Athletes","FeSc2","Inclusion Criteria:\n\n* Biologically female athlete\n* Age 16-35\n* At least one year past the age of menarche\n* Complete and pass the Get Active Questionnaire (GAQ)\n* Suboptimal ferritin levels (≤50 mcg\u002FL)\n* Provide informed consent to participate in study\n* Activity level based on Participant Classification Framework (McKay et al., 2022)\n\n  * Tier 3: Highly Trained \u002F National Level\n  * Tier 4: Elite \u002F International Level\n* Energy availability \\>30 kcal\u002Fkg LBM\n* Have access to a smartphone, tablet, or computer\n* Able to swallow a capsule sized 25mm length and 8mm width (i.e. large dose omega 3 pill)\n\nExclusion Criteria:\n\n* Non-English speaking\n* Anemic (hemoglobin \\\u003C120g\u002FL)\n* Regular prebiotic (fiber) or probiotic use within 4 weeks of study enrollment\n* Current laxative use\n* Are a smoker or use tobacco products\n* Consume \\>21 units of alcohol per week\n* Have donated blood in the previous 3 months\n* Have a BMI \\\u003C16 but \\>30kg\u002Fm2\n* Are dieting for weight loss or are following a low carbohydrate diet\n* Have participated in another clinical trial within the 30 days preceding study enrollment.\n* Known allergy of hypersensitivity to any ingredient, including non-medicinal ingredients, such as iron, yeast, cellulose, or maltodextrin\n* Are taking medications known to affect cardiovascular or metabolic responses to exercise such as beta-blockers, anti-coagulants etc. as assessed by the Principal Investigator\n* Known history of thalassemia or thalassemia trait\n* Known inherited bleeding disorder\n* Major surgery in the past 3 months\n* Chronic use of Salicylates, aspirin, corticosteroids, or nonsteroidal anti-inflammatory drugs\n* Have any of the following conditions: renal or gastrointestinal disorders, autoimmune disease, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions that are being treated and deemed to be able to significantly interfere with study intervention and assessment in the opinion of the Principal Investigator and Qualified Investigator\n* Have current musculoskeletal injuries that limit exercise capacity\n* Self-identifying with any kidney or gastrointestinal issues, metabolic disorders, cardiac conditions, vascular illnesses, rheumatoid arthritis, diabetes, compromised lung function, unregulated blood pressure, episodes of dizziness, thyroid complications, or any other health conditions under treatment that might potentially interfere with the study results\n* Orthopaedic issues that limit exercise ability\n* Currently\u002Flast 3 months taking prescription medications that are known to affect iron absorption (i.e. Antacids\u002FPPIs (e.g., omeprazole), H2 Blockers (e.g., ranitidine), Tetracycline Antibiotics (e.g., doxycycline), Quinolone Antibiotics (e.g., ciprofloxacin), Cholestyramine, Colchicine, Methyldopa.)\n* Currently taking levodopa or levothyroxine\n* Currently\u002Flast 3 months taking iron containing supplements\n* Are pregnant or lactating or planning to become pregnant for the duration of the study. All participants must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:\n\n  * Abstinence or agrees to use contraception if planning to become sexually active\n  * Hormonal contraceptives including oral contraceptives, hormone birth control patch\n  * Vaginal contraceptive ring, injectable contraceptives, or hormone implant\n  * Barrier methods (e.g. condoms with spermicide, diaphragms with spermicide)\n  * Intrauterine devices\n  * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)\n  * Vasectomy of partner at least 6 months prior to screening\n\nAdditional exclusion criteria based on use of SIMBA capsules. Following is a summary of SIMBA capsules specific exclusion criteria:\n\n* Currently pregnant, planning to become pregnant, or breastfeeding\n* Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring, narrowing, or obstruction with a risk of capsule non-excretion, including, e.g. achalasia, eosinophilic esophagitis, any IBD, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.\n* History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction\n* Have any gastrointestinal inflammatory diseases, including ulcerative colitis, Crohn's disease, microscopic colitis.\n* Use of any medication in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the study visit. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.\n\n  * Prokinetic (stimulate muscle contractions, Metoclopramide, Domperidone, Prucalopride, etc.) use. If you are not using prokinetics to treat SIBO, then you may be eligible after a 2-week washout period, and willing to not use prokinetics for the study duration.\n  * Unable to stop using laxatives or prokinetic medications for 4 days before the study procedure (breath test). Laxatives can be resumed after the test is conducted.\n* Have used antibiotics (except for topical use) in the previous 12 weeks. You may be eligible to participate once a 12-week washout is completed\n* Regular use of probiotics, prebiotics, or synbiotics (including food and drinks containing added probiotics and\u002For probiotic yogurts with live, active cultures)\n* Have digestive problems that slow or stop food from moving properly, like a slow stomach, blocked intestines, or stiffened tissues\n* Suffer from celiac disease (treated or untreated)\n* Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome\n* History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration\n* Have had a cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable)\n* Have trouble swallowing, which could cause a risk of choking on a capsule\n* Participants scheduled for an MRI at any time during the study. You may be eligible to participate once your MRI procedure is completed.\n* Have constant constipation (IBS-C) defined as a history of less than 3 bowel movements per week\n* Any prior fecal microbiota transplantation\n* Drug use\n* Suffer from alcohol or drug abuse\n* Females of childbearing potential will be asked about their likelihood of being pregnant, based on factors such as recent sexual activity or use of contraception. Their self-reported confirmation of non-pregnancy will be accepted unless they express uncertainty. In cases of doubt, a urine beta-HCG pregnancy test will be required for confirmation. If you become pregnant during the course of the study, you should stop taking the supplement immediately and inform the investigators. If you are using a supplement that the investigators have deemed to not interfere with the study's intervention or assessment (e.g. vitamins, omega-3, creatine monohydrate etc.), you will be permitted to continue taking these supplements. In all cases, participants will be instructed to not change the dose of the taken supplement or introduce a new supplement unless it is medically recommended.","16 Years","35 Years",{"count":184,"type":20},36,[23],"The goal of this clinical trial is to learn if different types and doses of oral iron supplements can improve iron levels, athletic performance, and gut health in young female athletes with low iron stores. The main questions it aims to answer are:\n\n* Does a low dose of yeast-bound iron improve iron status better than traditional iron supplements?\n* Do the different iron supplements cause fewer or more gastrointestinal (stomach) symptoms?\n* How do iron supplements affect exercise performance and gut bacteria?\n\nResearchers will compare three types of iron supplements:\n\n* A low-dose iron supplement (40 mg)\n* A low-dose yeast-bound iron supplement (40 mg)\n* A high-dose iron supplement (150 mg)\n\nThis will help researchers find out which type of supplement is most effective and easiest on the stomach.\n\nParticipants will:\n\n* Take one of the three assigned iron supplements every other day for 12 weeks\n* Complete fitness tests before and after the study, including cycling and jumping tests\n* Give blood samples to measure iron levels\n* Provide stool and intestinal samples to study gut bacteria\n* Swallow a SIMBA capsule before and after the study to collect a sample from the small intestine\n* Complete regular online surveys about sleep, stress, menstrual cycles, and gut symptoms",[26],[189,31,190,191,192,153,193,194,195,196,197,198,199,200,201,202],"iron","athletic performance","female athlete","iron supplements","hemoglobin","gastrointestinal","microbiome","Exercise test","Yeast","Saccharomyces cerevisiae","ferrous sulphate","ferrous sulfate","Body composition","exercise","2026-04-14",{"date":205,"type":38},"2026-04-17",{"date":207,"type":38},"2026-03-26",{"date":209,"type":20},"2026-09",{"name":211,"class":45},"University of Calgary",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":108,"sex":109,"minAge":17,"maxAge":182,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":46},"100599181","iron-absorption-and-losses-in-young-south-african-women-living-without-and-with-overweight-and-obesity-100599181","NCT07081152","Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity","Long-term Iron Absorption and Losses in Young South African Women Living Without and With Overweight and Obesity","RAYON","Inclusion Criteria:\n\n* Of African descent\n* BMI of 18.5 to 24.9 kg\u002Fm2 for participants living without OW\u002FOB and BMI ≥ 28 kg\u002Fm2 for participants living with OW\u002FOB\n* Having low to moderate inflammation-adjusted iron stores (ferritin ≤50 µg\u002FL)\n* Absence of low-grade inflammation (CRP\\\u003C2 mg\u002Fl) for participants living without OW\u002FOB and presence of low-grade inflammation CRP 2-20 mg\u002Fl) for participants living with OW\u002FOB\n* Planning to reside in the study area for at least 2 years\n\nExclusion Criteria:\n\n* Hemoglobin \\\u003C 11 g\u002Fdl\n* Treated or self-reported chronic or malabsorptive disorder\n* Current use of chronic anti-inflammatory medication, like corticosteroids or non-steroidal anti-inflammatory medication\n* Pregnancy or planning to become pregnant in the next 2 years\n* Lactation\n* Fear of needles or experiencing vaso-vagal episodes when exposed to blood\n* Difficulty drawing blood due to poor quality veins\n* Blood donation in the past 4 months or plans to donate blood during the study\n* On a weight-loss diet or program or planning to start the same during the study\n* Smoking\n* Unwillingness to stop taking iron and \u002For vitamin C-containing supplements during phase 1 of the study\n* Regular use of antacids, proton pump inhibitors or H2 blockers\n\nAdditional inclusion criteria applicable to phase 2 of the study\n\n* Labelled with stable iron isotope (tracer) for a minimum of one year\n* Willingness not to start or stop contraceptive use during the 6 months\n* BMI ≥ 18.5 to 24.9 kg\u002Fm2 for participants living without OW\u002FOB and BMI ≥ 28 kg\u002Fm2 for participants living with OW\u002FOB\n\nAdditional exclusion criteria applicable to phase 2 of the study\n\n\\- Blood transfusion, intravenous iron infusion, blood donation or significant blood loss during the equilibration period",{"count":221,"type":20},70,[23],"Young women living with obesity (OB) have a greater risk of developing iron deficiency. Plus, the risk of anemia and\u002For ID in young women living with overweight (OW) and obesity (OB) is further increased by inadequate dietary intake and\u002For poor bioavailability of iron, as well as gastrointestinal and menstrual iron losses. It is not certain whether women living with OW\u002FOB can meet their iron requirements from their day-to-day diet.\n\nThe aim of this study is to compare iron absorption and losses over a long period between women living with and without OW and OB. Secondary outcomes include iron and inflammation status, as well as dietary iron intake.",[225,26,226],"Obesity","Inflammation","2026-03-19",{"date":229,"type":38},"2026-03-23",{"date":231,"type":38},"2025-07-24",{"date":75,"type":20},{"name":234,"class":45},"Linda Malan",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":108,"sex":16,"minAge":17,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100626951","assessing-dietary-intake-of-selected-food-components-using-short-questionnaires-100626951","NCT07442305","Assessing Dietary Intake of Selected Food Components Using Short Questionnaires","Validation of Short Questionnaires for Assessing Dietary Intake of Selected Food Components","NutriPlant\u002FFFQ","Inclusion criteria:\n\n* Willingness to participate in the study.\n* Signed Statement of Informed and Voluntary Consent to Participate in the Study.\n* Age between 18 and 65 years at the time of enrolment in the study.\n* Willingness to comply with all study procedures and to keep a dietary record in accordance with the provided instructions.\n\nExclusion criteria:\n\n* Pregnancy or breastfeeding.\n* Specific dietary practices followed by a small proportion of the population (veganism, LCHF, calorie-restricted diets; note: vegetarians are not excluded).\n* Diets prescribed by medical professionals.\n* Mental incapacity that prevents adequate understanding or participation.\n\nReasons for excluding a participant during the study:\n\n* Inability to participate in the study\n* Wishes to discontinue participation\n* Incomplete data provided","65 Years",{"count":245,"type":20},50,"The aim of the study is to validate short questionnaires for assessing dietary intake of selected food components, with a focus on dietary fibre and iron. Two internationally developed short questionnaires (FiberScreen \\[for dietary fibre\\] and IRONQ-FFQ \\[for iron\\]) were adapted to the Slovenian context and will be compared with the standard 24-hour dietary recall method.",[248,63,249],"Nutritional Status","Diet",[251,252,253,189,254,255],"dietary intake","nutritional status","micronutrients","ffq","food recall","NOT_YET_RECRUITING","2026-02-27",{"date":259,"type":38},"2026-03-02",{"date":261,"type":20},"2026-03-01",{"date":263,"type":20},"2027-12-31",{"name":265,"class":45},"Institute of Nutrition, Slovenia (Nutris)",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":46},"100435092","phase-4-impact-of-intravenous-iron-repletion-on-mechanisms-of-exercise-intolerance-in-hfpef-ironmet-hfpef-100435092","NCT04945707","Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)","A Double-blind,Randomized, Placebo-controlled Study to Assess Exercise Tolerance After Iron Repletion With Ferric Derisomaltose (Monoferric®) IV Compared to Placebo in Heart Failure With Preserved Ejection Fraction and With Iron Deficiency.","IRONMETHFpEF","Inclusion Criteria:\n\n1. Adult (≥18 years of age) able to provide informed consent.\n2. Stable heart failure (NYHA II-IV) for at least 4 weeks\n3. Heart Failure with Preserved left ventricular ejection fraction.(Left ventricular ejection fraction ≥ 50 % obtained within 6 months of informed consent.\n4. NT-proBNP ≥ 125 pg\u002FmL without ongoing atrial fibrillation\u002Fflutter. If ongoing atrial fibrillation\u002Fflutter at the time of sample collection, NT-proBNP must be ≥ 250 pg\u002FmL OR patients must have a history of pulmonary capillary wedge pressure ≥ 15 mm Hg during rest or the slope of pulmonary capillary wedge pressure to cardiac output (PCWP\u002FCO) ≥ 2.0 mmHg\u002FL\u002Fmin during upright exercise (Eisman et al., Circ Heart Fail. 2018 May;11(5):e004750.).OR subjects must have a heart failure hospitalization within the last 12 months prior to screening OR Chronic diastolic dysfunction on echocardiography as evidenced by: Left Atrial Enlargement (LAE): LA diameter ≥ 3.8cm in women, ≥ 4.0 cm in men or LA length ≥ 5.0 cm or LA area ≥ 20 cm2 OR LA volume ≥ 55mL or LA volume index ≥ 29ml\u002Fm2 or Left Ventricular Hypertrophy (LVH): septal thickness or posterior wall thickness ≥ 1.1 cm OR For patients in sinus rhythm: E\u002Fe' ratio ≥15 at septal annulus, or E\u002Fe' ratio ³13 at lateral annulus, or average E\u002Fe' ratio ³14. For patients in atrial fibrillation: E\u002Fe' ≥ 11 at the septal annulus.\n5. Hemoglobin \\>9.0 g\u002FdL AND \\\u003C15.0 g\u002FdL .\n6. Serum ferritin \\\u003C100 ng\u002FmL OR 100 to 300 ng\u002FmL with TSAT \\\u003C20%, but NOT ferritin \\\u003C 15 ng\u002FmL.\n7. Demonstrate diminished exercise capacity: ≤ 75 % predicted peak VO2 as determined by a Cardiopulmonary Exercise Test (CPET) at the time of screening\n8. Perform a maximal effort CPET by achieving a Respiratory Exchange Ratio (RER) of ≥ 1.05\n\nExclusion Criteria:\n\n1. Current or planned intravenous iron supplementation. Iron-containing multivitamins (\\\u003C30 mgs \u002Fday) are permitted.\n2. Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®)\n3. History of acquired iron overload (e.g. hemochromatosis), or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.\n4. Documented active gastrointestinal bleeding\n5. Anemia with known cause other than iron deficiency or chronic disease\n6. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months of enrollment.\n\n7 Presence of any condition that precludes exercise testing such as:\n\na. Claudication that limits exertion b. Uncontrolled bradyarrhythmia or tachyarrhythmia (according to Investigator judgment, pacemaker treatment is allowed as long as the same pacing mode\u002Factivity can be used at baseline and follow-up CPET) c. Clinically significant musculoskeletal disease or orthopedic conditions that limit the ability to perform the CPET (e.g., arthritis or injury in the foot, leg, knee or hip) d. Severe obesity (BMI \\> 50.0 kg\u002Fm2) e. Any other non-heart failure condition that, in the opinion of the Investigator, that is the primary limitation to exercise. 8. Severe renal dysfunction (eGFR\\\u003C 20 ml\u002Fmin\u002F1.73m2) 9. Severe liver disease (ALT or AST \\> 3x upper limit of normal, alkaline phosphatase or bilirubin \\>2x upper limit of normal) 10. Active malignancy other than non-melanoma skin cancers 11. Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.\n\n12\\. Planned surgical procedure during the trial period 13. Inability to return for follow up visits",{"count":275,"type":20},66,[277],"PHASE4","The primary objective of this study is to determine if the correction of functional iron deficiency by administering a single dose of intravenous iron (ferric derimaltose or Monoferric®) in participants with heart failure with preserved ejection fraction (HFpEF) will improve exercise capacity as measured by the change in peak oxygen uptake (peak VO2) from baseline to 12 weeks.",[63,280],"Heart Failure With Preserved Ejection Fraction",[282,26],"Heart Failure with Preserved Ejection Fraction","2026-02-17",{"date":285,"type":38},"2026-02-19",{"date":287,"type":38},"2021-11-26",{"date":289,"type":20},"2026-07-31",{"name":291,"class":45},"Massachusetts General Hospital",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100620590","phase-4-the-impact-of-iv-iron-on-exercise-capacity-and-quality-of-life-in-pulmonary-hypertension-100620590","NCT07359599","The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension","A Randomized, Double-blind, Placebo-controlled, Multicentre Trial, Assessing the Impact of Ferric Carboxymaltose on Exercise Capacity and Functional Status in Pulmonary Hypertension","IRON-PH","Inclusion Criteria:\n\n* ≥18 years of age\n* WHO functional class II - IV\n* Iron deficiency defined as TSAT \\\u003C21% (no more than ≥3 months old at randomization)\n* PH defined by echocardiography and\u002For right heart catheterization (RHC) according to the following WHO groups:\n\n  * Group 1 PH:\n\n    * Patients with a diagnosis of idiopathic PAH, hereditary PAH, drug induced PAH or PAH and associated with CTD or CHD (historical RHC available) on stable and optimized doses of PAH targeted therapies for at least 4 weeks before randomization.\n    * Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines.\n  * Group 2 PH and baseline LVEF \\> 50% on imaging modality within last 6 months before randomization and on stable doses of loop diuretics and HFpEF therapies for 4 weeks. Group 2 PH can be included based on echocardiography or RHC.:\n\n    * Echocardiography (\\\u003C6mo before randomization):\n\n      * Presence of LVH or LA-enlargement\n      * E\u002Fe' \\>15 (at rest or exercise)\n      * TRVmax \\>2.8 m\u002Fs (at rest) or mPAP\u002FCO\\>3 mHg\u002FL\u002Fmin (exercise) or echocardiographic evidence of high or intermediate probability for PH as per 2022 ESC PH guidelines.\n    * RHC (\\\u003C6mo before randomization)\n\n      * mPAP \\> 20 mmHg\n      * PCWP \\> 15 mmHg at rest or PCWP\u002FCO-slope \\> 2mmHg\u002FL\u002Fmin or exercise PCWP\\>25mmHg, or PCWP 13-15 mmHg with elevation ≥18mmHg after 500 cc Fluid Challenge\n  * Group 4 PH:\n\n    * Inoperable CTEPH\n    * Persistent\u002Frecurrent CTEPH (\\> 1 year after endarterectomy or \\> 6 months after balloon pulmonary angioplasty) ineligible for balloon pulmonary angioplasty.\n    * Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines.\n\nExclusion Criteria:\n\n* Screening haemoglobin \\\u003C 8 g\u002Fdl or \\>15 g\u002Fdl\n* Ferritin \\> 700 ng\u002FmL\n* Known hypersensitivity reaction to any component of FCM\n* Group 1 PH associated with veno-occlusive diseases.\n* Primary diagnosis of group 3 PH\n* Primary diagnosis of group 5 PH\n* Treatment with oral or other IV iron therapies at screening.\n* Current or planned mechanical circulatory support or lung\u002Fheart transplantation.\n* Any planned surgery or procedure leading to expected significant blood loss (defined as more than 250 ml = equal to 125mg of iron).\n* Haemodialysis or peritoneal dialysis (current or planned within the next 24 weeks).\n* Inability to return for follow up visits within the necessary windows\n* Concurrently in a study with another investigational product.\n* Uncorrected moderate to severe aortic stenosis (AVA \\\u003C1.5cm² and mean gradient \\>20 mmHg) or severe valvular regurgitation (except tricuspid regurgitation)\n* Impression by investigator that patient cannot perform a 6MWT\n* Active infection as judged by the investigator.\n* Pregnancy or desire to become pregnant during the study duration.",{"count":301,"type":20},306,[277],"Pulmonary hypertension (PH) is a condition characterized by elevated blood pressure in the pulmonary arteries. This leads to symptoms such as shortness of breath and a significantly reduced exercise capacity, resulting in a very poor quality of life. Currently, treatment options for PH are limited.\n\nMore than 60% of patients with PH develop iron deficiency. Studies have shown that this deficiency is associated with more severe symptoms, reduced exercise capacity, and even lower quality of life. Oral iron supplements are often ineffective in these patients due to impaired absorption in the intestines, caused by chronic low-grade inflammation-a common feature in PH.\n\nIntravenous iron administration can rapidly correct the deficiency, but it remains unclear whether this also leads to clinical improvements such as enhanced exercise capacity, reduced shortness of breath, and improved quality of life. Moreover, the cost-effectiveness of this treatment is still unknown. The IRON-PH study aims to answer these questions.\n\nAs part of the IRON-PH study, 306 patients with pulmonary hypertension will be enrolled. Each patient will be randomized to receive either intravenous iron (ferric carboxymaltose) or intravenous placebo (NaCl 0.9%).",[305,26],"Pulmonary Hypertension","2026-01-28",{"date":308,"type":38},"2026-01-30",{"date":310,"type":38},"2026-01-27",{"date":312,"type":20},"2028-10",{"name":314,"class":45},"Ziekenhuis Oost-Limburg",7,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":243,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":332,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":46},"100621443","phase-4-iron-infusion-in-patients-undergoing-transcatheter-aortic-valve-implantation-100621443","NCT07370688","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial","IRON TAVI","Inclusion Criteria:\n\n* Patient age ≥ 65 years\n* Patients with severe AS and ID undergoing successful TAVI\n* ID defined as Ferritin \\\u003C 100 ug\u002FL and\u002For Transferrin saturation \\\u003C 20%\n* Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Contra-indication for TAVI\n* Ferritin \\> 400 ug\u002FL\n* Hemoglobin \\\u003C5.6 mmol\u002FL or \\\u003C9 g\u002FdL\n* Hemoglobin \\>8.7 mmol\u002FL or \\>14 g\u002FdL in men and \\>8.1 mmol\u002FL or \\>13 g\u002FdL in women\n* Anaemia due to known reasons other than ID and\u002For anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding)\n* Chronic liver disease (including active hepatitis) and\u002For screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.\n* Renal dialysis (previous, current, or planned within the next 6 months) or MDRD\u002FCKD-EPI estimated glomerular filtration rate \\\u003C15 mL\u002Fmin.\n* History of iron overload\n* History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and\u002For such therapy planned within next 6 months\n* Clinically apparent infection requiring antibiotic treatment\n* Known hypersensitivity to iFCM or to any of its excipients\n* Pregnancy\n* Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and\u002For quality of life assessment.",{"count":325,"type":20},402,[277],"The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI).\n\nThe main questions it aims to answer are:\n\n1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?\n2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?\n\nThe intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)).\n\nParticipants will:\n\n* Provide written informed consent\n* Be randomly assigned to one of two groups:\n\n  1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks)\n  2. Control group: receiving standard of care (= no iron therapy)\n* Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI.\n* During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)",[329,26,330,331],"Aortic Valve Stenosis","TAVI(Transcatheter Aortic Valve Implantation)","Cardiovascular Diseases",[333,334,335,329,336,337,338,26,331],"Health-related Quality of Life","Six-Minute Walk Test","Randomized Controlled Trial","Intravenous Iron Therapy","Kansas City Cardiomyopathy Questionnaire","Functional Recovery","2026-01-18",{"date":310,"type":38},{"date":342,"type":38},"2024-08-12",{"date":344,"type":20},"2028-07",{"name":346,"class":45},"Erasmus Medical Center",{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":4},"100614249","impact-of-iron-deficiency-on-arrhythmic-events-and-resting-ecg-abnormalities-in-patients-hospitalized-with-heart-failure-100614249","NCT07277140","Impact of Iron Deficiency on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure","Impact of Iron Deficiency With and Without Anemia on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure","Inclusion Criteria:\n\nAdult patients (≥18 years) admitted to Assiut University Heart Hospital with a clinical diagnosis of heart failure (new-onset or decompensated).\n\nIncludes all ejection fraction categories (HFrEF, HFmrEF, and HFpEF).\n\nAvailability of 12-lead ECG, serum iron studies (ferritin, transferrin saturation, serum iron), and routine laboratory tests.\n\nWillingness to participate and provide informed consent.\n\nExclusion Criteria:\n\nKnown history of primary electrical disorders (e.g., Brugada syndrome, Long QT syndrome, etc.).\n\nRecent intravenous iron therapy or blood transfusion within the past 3 months.\n\nEnd-stage renal disease requiring dialysis.\n\nKnown anemia due to non-iron-deficiency causes (e.g., hemolytic anemia, active malignancy, etc.).\n\nSevere electrolyte imbalances (e.g., significant hypo-\u002Fhyperkalemia, hypo-\u002Fhypermagnesemia).\n\nActive systemic infection, chronic inflammatory conditions, or recent chemotherapy.\n\nsevere valvular lesions",{"count":355,"type":20},300,"The relationship between iron deficiency (with or without anemia) and arrhythmic risk or ECG abnormalities in hospitalized HF patients remains poorly characterized. This is particularly relevant in settings where advanced iron therapies (e.g., intravenous iron supplementation) may not be readily available, and where simple clinical and electrocardiographic markers could help identify high-risk patients by evaluating the impact of iron deficiency (with and without anemia) arrhythmic events and resting ECG changes among patients admitted with heart failure. Understanding these associations may offer insights into the arrhythmogenic potential of iron deficiency and support the integration of iron status assessment into routine risk stratification and management of HF patients.",[358,26],"Heart Failure","2025-12-10",{"date":361,"type":38},"2025-12-11",{"date":363,"type":20},"2025-12-15",{"date":365,"type":20},"2027-10-01",{"name":367,"class":45},"Assiut University",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":16,"minAge":376,"maxAge":110,"enrollmentInfo":377,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":380,"conditions":381,"keywords":388,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":398,"locationsCount":46},"100609691","phase-2-intravenous-iron-in-kids-with-iron-deficiency-and-scoliosis-study-100609691","NCT07217873","IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study","IntraVenous Iron in Kids With Iron Deficiency and Scoliosis","IV-KIDS","Inclusion Criteria:\n\n* 10 -19 years old\n* diagnosis of scoliosis or kyphosis\n* scheduled for imminent spinal fusion procedure (\\\u003C6 weeks) at MS-CHONY\n* Iron deficiency or hypoferritinemia, defined as serum ferritin less than or equal to 50 μg\u002FL\n\nExclusion Criteria:\n\n* C-reactive protein \\> 10 mg\u002FL\n* receiving nutritional support by report in the medical chart\n* self-reported history of hypersensitivity reaction to iron-containing supplements\n* self-reported history of receiving intravenous iron supplements\n* self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis\n* objection to receiving red blood cell transfusions\n* current pregnancy (identified by self-report or documentation of preoperative screening test in the medical record)\n* prisoners\n* patient or parent decides against study participation","10 Years",{"count":57,"type":20},[59,379],"PHASE3","Adolescents and young adults undergoing spinal fusion surgery for the correction of scoliosis and other spinal deformity are at high risk of perioperative iron deficiency and anemia, yet the means and evidence for optimizing iron status have not been described in this setting. The proposed study is a randomized controlled trial of preoperative intravenous iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in this vulnerable population. Building evidence for patient blood management interventions such as iron supplementation is vital to ensuring high quality care of surgical patients and may reduce unnecessary transfusions amid recent blood shortages.",[382,26,383,384,385,386,387],"Scoliosis Correction","Transfusion Blood","Surgery Complications","Spinal Fusion","Scoliosis Idiopathic Adolescent","Scoliosis Neuromuscular",[389,31,390,391,151],"scoliosis","blood transfusion","spinal fusion","2025-11-21",{"date":394,"type":38},"2025-11-26",{"date":392,"type":38},{"date":397,"type":20},"2027-10-31",{"name":399,"class":45},"Columbia University",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":415,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":46},"100536874","phase-4-effect-of-oral-sucrosomial-iron-on-exercise-capacity-and-quality-of-life-in-patients-with-heart-failure-100536874","NCT06270498","Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure","Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure: a Randomized, Placebo-controlled Trial (RISE-HF)","RISE-HF","Inclusion Criteria:\n\n1. Chronic HF (New York Heart Association \\[NYHA\\] functional class II-IV) patients, on optimal therapy, and clinically stable for at least 4 weeks with no dose changes of HF drugs\n2. LVEF\\\u003C50% at screening visit (historical value can be used if performed within 6 months of screening visit)\n3. Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg\u002FmL (or BNP ≥75 pg\u002FmL) for patients in normal sinus rhythm; ≥1,000 pg\u002FmL (or BNP ≥400 pg\u002FmL) for patients in atrial fibrillation\n4. TSAT \\\u003C20%\n5. Hemoglobin 10.0-16.0 g\u002FdL\n6. Rapid iron repletion with intravenous iron is not considered a clinical necessity by physicians after reviewing patient medical record (if anaemia is present, its grade is no more than mild)\n7. Age ≥18 years, male and female\n8. Willingness to provide informed consent\n9. Subjects who decide to use single or dual contraceptive methods to avoid conceiving during the study period\n\nExclusion Criteria:\n\n1. Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing\n2. Exercise training program in the previous 3 months, or planned in the next 3 months\n3. Recent (\\\u003C3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke\n4. Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis\n5. Atrial fibrillation or flutter with a ventricular response rate of \\>100 beats per minute at rest\n6. Temperature ≤38 °C (oral or equivalent) or active infection as defined by current use of oral or intravenous antimicrobial agents\n7. Need for blood transfusion within the last month\n8. Hb\\\u003C10 g\u002FdL or Hb\\>16 g\u002FdL\n9. Rapid iron repletion with intravenous iron is considered a clinical necessity by physicians after reviewing patient medical record\n10. Documented active gastrointestinal bleeding\n11. Oral iron, i.v. iron or erythropoietin stimulating agent within the last 3 months\n12. eGFR ≤15 mL\u002Fmin or on hemodialysis\n13. Chronic liver disease and\u002For alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range\n14. Active cancer\n15. Evidence of iron overload (ferritin \\>400 ng\u002FmL)\n16. Hypersensitivity to any of the study products or known severe allergies\n17. Participation in another study\n18. Low body weight (≤35 kg)\n19. Known or anticipated pregnancy in the next 4 months\n20. Need for forbidden medications\n21. Breastfeeding\n22. Consumption of iron-rich foods or any food that alter iron absorption (i.e. food rich in vitamin C) due to dietary requirements\n23. Any pathological condition or disease associated with a reduction or an impairment of intestinal iron absorption (i.e., prior gastrectomy, atrophic gastritis, bariatric surgery, coeliac disease)",{"count":409,"type":20},60,[277],"The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID).\n\nThe main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo.\n\nOne group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo.",[413,63,414],"Chronic Heart Failure","Left Ventricular Systolic Dysfunction",[416,31,417],"heart failure","sucrosomial iron","2025-09-25",{"date":420,"type":38},"2025-10-01",{"date":422,"type":38},"2024-03-14",{"date":424,"type":20},"2026-06-14",{"name":426,"class":45},"Raffaele De Caterina",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":108,"sex":109,"minAge":17,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":21,"phases":437,"briefSummary":439,"conditions":440,"keywords":441,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":46},"100599423","early-phase-1-effects-of-iron-supplementation-on-skeletal-muscle-properties-in-females-with-suboptimal-iron-storage-100599423","NCT07084298","Effects of Iron Supplementation on Skeletal Muscle Properties in Females With Suboptimal Iron Storage","Effects of 12 Weeks of Oral Iron Supplementation on Skeletal Muscle Iron Content, Mitochondrial Function, and Indices of Aerobic Fitness in Healthy Females With Suboptimal Iron Stores","MyoIRON","Inclusion Criteria:\n\n* biologically female\n* between the ages of 18-40 years of age at the time of enrolment\n* plasma ferritin ≤ 50 µg\u002F L (RCT) or \\>50 µg\u002FL (controls)\n* complete Get Active Questionnaire (GAQ: Canadian Society for Exercise Physiology) without contraindication\n\nExclusion Criteria:\n\n* have a body mass index (BMI) \\> 30 kg\u002Fm2\n* taking medications that have been shown to affect cardiovascular, respiratory, or metabolic responses to exercise (e.g., β-blockers, anti-inflammatories, anti-coagulants, insulin, etc.)\n* hemoglobin ≤ 120 g\u002FL (anemia cut-off for women)\n* have known health problems or contraindications that prohibit exercise, including renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, arthritis, diabetes, respiratory disease, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions that are being treated and deemed likely to confound the results\n* dieting for weight loss or following a low-carbohydrate diet (known to affect iron homeostasis)\n* history of smoking or using tobacco products\n* consuming excessive amounts of alcohol (\\>21 units\u002Fweek)\n* supplementing with iron (\\>5mg\u002Fday) in the last 3 months\n* any blood donation or surgeries in the past 3 months\n* antibiotic use within the previous four weeks before study enrolment\n* current laxative use\n* known history of thalassemia\n* known bleeding disorder\n* chronic use of nonsteroidal anti-inflammatory drugs\n* Currently\u002Flast 3 months taking prescription medications that are known to affect iron absorption (i.e. Antacids\u002FPPIs (e.g., omeprazole), H2 Blockers (e.g., ranitidine), Tetracycline Antibiotics (e.g., doxycycline), Quinolone Antibiotics (e.g., ciprofloxacin), Cholestyramine, Colchicine, Methyldopa).\n* currently pregnant or plans to get pregnant within the duration of the study, and\n* do not understand English\n* Participants will be removed from the study if they begin taking any other forms of supplemental iron or choose to donate blood","40 Years",{"count":184,"type":20},[438],"EARLY_PHASE1","The goal of this clinical trial is to learn whether oral iron supplementation will increase skeletal muscle iron storage and its effects on exercise capacity in females with suboptimal iron status. The study will include healthy females, ages 18-40, who either have suboptimal or optimal iron stores.\n\nThe main questions it aims to answer are:\n\n* Does iron supplementation increase skeletal muscle iron storage and alter the expression of iron-related and mitochondrial proteins?\n* Does iron supplementation improve single-leg exercise performance?\n* Is serum ferritin correlated with the abundance of iron-related proteins in skeletal muscle?\n\nResearchers will compare outcomes from females with suboptimal iron status who receive oral iron supplementation to those who receive a placebo to see if supplementation improves muscle iron storage, protein expression, and exercise performance. Additionally, a non-intervention control group with optimal iron status will be included to assess baseline differences.\n\nParticipants will:\n\n\\- Be randomly assigned to receive 150 mg elemental iron or placebo (maltodextrin) every other day for 12 weeks\n\nComplete pre- and post-supplementation testing, including:\n\n* Blood draws to assess iron status\n* Skeletal muscle biopsies to analyze protein content\n* Whole-body and single-leg exercise tests to assess performance\n* Controls will undergo baseline-only testing to compare physiological and biochemical markers",[26],[189,31,190,191,192,153,193,442,443,444,445,446,202,447],"muscle","muscle ferritin","mitochondria","critical power","aerobic fitness","placebo","2025-07-31",{"date":450,"type":38},"2025-08-06",{"date":452,"type":20},"2025-08",{"date":454,"type":20},"2026-06",{"name":211,"class":45},{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":108,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":463,"targetDuration":465,"studyType":88,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":46},"100524929","peppi-study-identification-of-women-at-risk-for-placental-dysfunction-100524929","NCT06115122","PEPPI Study: Identification of Women at Risk for Placental Dysfunction","PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy","Mothers\n\nInclusion Criteria for PEPPI-study\n\n* Pregnant (first trimester)\n* Understands Finnish\n* ≥18 years\n* Signed informed consent\n\nExclusion Criteria\n\n* Multiple pregnancy\n* Miscarriage\u002Ftermination of the index pregnancy\n* No first trimester blood sampling\n\nInclusion Criteria for FERPPI-study\n\n* Participates in PEPPI-study (criteria above)\n* Blood samples at first and third trimester of pregnancy\n* Permits blood sampling from the umbilical cord when the baby is born\n\nExclusion Criteria\n\n* No first or third trimester blood sampling\n* No umbilical cord blood sample after baby is born\n\nFathers\n\nInclusion Criteria\n\n* Biological father to the child born for the mother who participated in PEPPI study\n* ≥18 years\n* Signed informed consent\n\nExclusion Criteria\n\n• Does not understand Finnish\n\nChildren\n\nInclusion Criteria for PEPPI-study\n\n* Born to mother who participated in PEPPI study\n* Signed informed consent from parent(s)\n\nExclusion Criteria\n\n• No consent from parent(s)\n\nInclusion Criteria for PEPPI-offspring study • Mother in risk-, control-, or PCOS group during PEPPI-study with ultrasound information at gestational weeks 30-32 or a mother who developed pre-eclampsia during the pregnancy regardless of their study group during PEPPI-study\n\nExclusion Criteria\n\n• Mother\u002Ffather declines participation\n\nInclusion Criteria for FERPPI-study\n\n* Signed informed consent from parent(s)\n* Mother has blood samples taken at first and third trimester (iron status)\n* Child has blood samples taken at birth and at 3 months of age\n\nExclusion Criteria\n\n* No consent from parent(s)\n* No blood samples from mother\n* No blood samples from child",{"count":464,"type":20},3000,"15 Years","The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a Finnish general population.\n\nCondition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome",[468,469,470,63,331,471,472],"Pre-Eclampsia","Intrauterine Growth Restriction","Polycystic Ovary Syndrome","Hypertensive Disorder of Pregnancy","Proteinuria in Pregnancy",{"date":474,"type":38},"2025-08-05",{"date":476,"type":38},"2022-02-15",{"date":478,"type":20},"2041-12-31",{"name":480,"class":45},"Oulu University Hospital",{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":108,"sex":109,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":491,"conditions":492,"keywords":500,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":510,"locationsCount":46},"100599361","non-invasive-detection-of-iron-deficiency-in-obstetrics-100599361","NCT07083492","Non-invasive Detection of Iron Deficiency in Obstetrics","Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)","PICCOLINO","Inclusion Criteria:\n\n* any timepoint during or up to 3 months after pregnancy\n* age ≥ 18 years\n* written informed consent\n\nExclusion Criteria:\n\n* previous participation in this study\n* refusal of blood sampling\n* incapacity to give informed consent",{"count":490,"type":20},500,"Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy.\n\nIn addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.",[493,63,494,495,496,497,498,499],"Iron Deficiency Anemia of Pregnancy","Restless Leg Syndrome in Pregnancy","Restless Leg Syndrome Due to Iron Deficiency Anaemia","Postpartum Hemorrhage","Postpartum Depression","Pregnancy Anemia","Iron Deficiency (Without Anemia)",[501,502,503,504],"Zinc protoporphyrin","Non-invasive detection","Obstetric anesthesia","Patient blood management","2025-07-23",{"date":231,"type":38},{"date":508,"type":38},"2022-11-15",{"date":97,"type":20},{"name":511,"class":45},"Wuerzburg University Hospital",{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":529,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":46},"100597052","phase-4-ironica-iron-repletion-in-heart-failure---a-comparison-of-oral-and-iv-approaches-100597052","NCT07053475","IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches","IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches","IRONICA","Inclusion Criteria:\n\n* Age ≥18 years\n* BMI ≥18.0 kg\u002Fm²\n* Hemoglobin:\n\n\\> 9 g\u002FdL and \\\u003C14 g\u002FdL for men \\> 9 g\u002FdL and \\\u003C13 g\u002FdL for women\n\n* Diagnosed with Congestive Heart failure:\n\nHFrEF: EF ≤40% in any recent echocardiogram HFpEF: EF ≥50-55% without any prior EF ≤40%, and evidence of diastolic dysfunction per ASE\u002FEACVI 2023 criteria-defined as either grade ≥2 or ≥2 supporting echo parameters (septal e' \\\u003C7 cm\u002Fsec or lateral e' \\\u003C10 cm\u002Fsec, E\u002Fe' ≥15, TR velocity \\>2.8 m\u002Fs, LA volume index ≥34 mL\u002Fm², LV septal or posterior wall thickness ≥1.2 cm, or LA area ≥20 cm² \u002F diameter ≥3.8 cm.\n\n* Documented elevated NT-proBNP based on BMI and rhythm:\n\nBMI \\\u003C35: ≥220 pg\u002FmL (NSR) or ≥660 pg\u002FmL (A-Fib) BMI ≥35: ≥125 pg\u002FmL (NSR) or ≥375 pg\u002FmL (A-Fib)\n\n* NYHA Class II-IV\n* Transferrin saturation (TSAT) \\\u003C20%\n* Hemoglobin \\\u003C14 g\u002FdL for men, \\\u003C 13 g\u002FdL for women.\n* Stable on heart failure therapy for ≥2-4 weeks\n* Currently prescribed a diuretic at home\n* Ambulatory (able to walk \\>20 ft with minimal assistance)\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Received IV iron, ESA, or blood transfusion within the last 6-12 months\n* Received high-dose oral iron (\\>100 mg\u002Fday in past 7 days)\n* Severe renal impairment (eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m² or on dialysis)\n* Patients with known cirrhosis or transaminitis with AST \\>141 or ALT \\>112 IU\u002FL\n* Active bleeding or known bleeding disorder\n* Recent cardiac surgery, myocardial infarction, or stroke within past 3 months\n* Active infection, defined as any systemic or deep-seated infection (e.g., bacteremia, sepsis, osteomyelitis, or infections requiring IV antibiotics or hospitalization) at the time of screening.\n* Active malignancy or undergoing chemotherapy\u002Fradiotherapy\n* Vitamin B12 or folate deficiency (unless corrected prior to enrollment)\n* Chronic liver disease (with LFTs \\>3× upper limit of normal)\n* Pregnant or breastfeeding women or those not using effective contraception\n* Lacks capacity to consent or unable to comply with study procedures","100 Years",{"count":522,"type":20},250,[277],"The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent.\n\nThe main questions the study will answer are:\n\n1. Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks?\n2. Does IV iron improve symptoms and quality of life more than oral iron?\n3. How do the two treatments compare for safety, side effects, and hospital readmissions\u002F mortality?\n\nResearchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better.\n\nWhat participants will do\n\n* Be randomly assigned by (like flipping a coin) to IV iron or oral iron.\n* Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks.\n* Visit the infusion clinic at 6 weeks for second dose of IV iron if needed.\n* Visit the clinic at 12 weeks for a follow-up to gather follow-up data including\n\n  1. A 6-minute walk test\n  2. Brief symptom and quality-of-life surveys\n  3. Blood tests to measure serum iron, ferritin, and transferrin saturation\n\nThis study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.",[358,526,527,26,528],"Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Failure With Preserved Ejection Fraction (HFPEF)","Iron-deficiency Anemia (IDA)",[530,531,532,533,534,535,536,537,538,539,540,541,542],"Intravenous iron","Oral iron","Ferric carboxymaltose","Ferrous sulfate","Transferrin saturation (TSAT)","Functional iron deficiency","6-minute walk test (6MWT)","Kansas City Cardiomyopathy Questionnaire (KCCQ)","Quality of life","Randomized controlled trial","Congestive heart failure","HFpEF","HFrEF","2025-06-26",{"date":545,"type":38},"2025-07-08",{"date":547,"type":38},"2025-04-02",{"date":549,"type":20},"2027-03-31",{"name":551,"class":45},"Syed Hamza Mufarrih",{"id":553,"slug":554,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":109,"minAge":17,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":21,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":46},"100470601","phase-3-ferric-derisomaltose-and-outcomes-in-the-recovery-of-gynecologic-oncology-eras-enhanced-recovery-after-surgery-100470601","NCT05407987","Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)","Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study","FORGE II","Inclusion Criteria:\n\n1. Signed written informed consent prior to initiation of any study specific activities\u002Fprocedures.\n2. Age ≥ 18 years old.\n3. Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:\n\n   1. The indication for the operation may be for suspected or proven gynecologic malignancy.\n   2. Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1.\n   3. The expected time from recruitment to surgery is 28-90 days.\n4. Screening haemoglobin less than 120 g\u002FL and transferrin saturation (TSAT) \\\u003C20%.\n5. Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.\n6. Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment).\n7. WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.\n8. Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks.\n\nExclusion Criteria:\n\n1. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \\>50%.\n2. Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy).\n3. Known hypersensitivity to Ferric derisomaltose\u002Firon isomaltoside (Monoferric®) or its excipients.\n4. Temperature \\>38C or patient on non-prophylactic antibiotics.\n5. Known chronic liver disease or active hepatitis.\n6. Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.\n7. Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range.\n8. Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo).\n9. Unfit for elective surgery.\n10. Pregnancy or lactation.\n\n1\\. Unable to fully comprehend and\u002For perform study procedures and patients with psychiatric illness\u002Fsocial situations\u002Fsubstance abuse that would limit compliance with study requirements.\n\n11\\. Cervical cancer with a clinical stage of 2A or greater.",{"count":561,"type":20},82,[379],"Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates.\n\nThis is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia.\n\nThe study aims to assess the effectiveness of preoperative ferric derisomaltose\u002Firon isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.",[565,566,63],"Gynecologic Cancer","Anemia","2025-04-23",{"date":569,"type":38},"2025-04-25",{"date":571,"type":38},"2025-04-08",{"date":573,"type":20},"2026-12-30",{"name":575,"class":45},"AHS Cancer Control Alberta",{"id":577,"slug":578,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":11,"sex":16,"minAge":583,"maxAge":17,"enrollmentInfo":584,"targetDuration":4,"studyType":21,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":606},"100586896","iron-deficiency-in-pediatric-celiac-disease-diet-vs-iron-supplementation-trial-100586896","NCT06921343","Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial","Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.","Inclusion Criteria:\n\n* Children aged 18 months to 18 years\n* Newly diagnosed with celiac disease (based on ESPGHAN guidelines)\n* Ferritin levels below 15 ng\u002FdL\n* Normal hemoglobin, MCV, and MCH levels for age and sex\n\nExclusion Criteria:\n\n* IgA deficiency preventing TTG antibody monitoring\n* Potential celiac disease (positive serology with normal intestinal histology)\n* Underlying diseases that may cause anemia (e.g., Inflammatory bowel disease, eosinophilic gastrointestinal disease, certain gastritis types)\n* Diseases affecting iron absorption (e.g., Cystic Fibrosis)\n* Congenital anemia (e.g., Thalassemia, hereditary spherocytosis)\n* Prior iron supplementation (\\>14 days oral iron within 2 months or IV iron within 6 months before diagnosis)","18 Months",{"count":585,"type":20},150,[23],"This study aims to understand how to best manage iron deficiency in children newly diagnosed with celiac disease. Many children with celiac disease have low iron levels, even if they do not have anemia. While some doctors recommend iron supplements, others believe that simply following a gluten-free diet may be enough to restore iron levels naturally.\n\nIn this study, children with newly diagnosed celiac disease and low iron levels (but normal hemoglobin) will be randomly assigned to one of two groups:\n\nGluten-Free Diet Only - No additional iron supplements Gluten-Free Diet + Iron Supplementation Researchers will compare iron store levels over one year to see if iron supplements provide any additional benefit beyond the gluten-free diet alone. The study will also track possible side effects of iron supplements, such as stomach discomfort.\n\nThis study will help doctors determine the best approach to managing iron deficiency in children with celiac disease, ensuring they receive the safest and most effective treatment.",[589,26],"Celiac Disease in Children",[591,592,593,594,595,596],"Celiac disease","Pediatric celiac disease","Iron deficiency","Ferritin levels","Gluten-free diet","Iron supplementation","2025-04-03",{"date":599,"type":38},"2025-04-10",{"date":601,"type":20},"2025-04",{"date":603,"type":20},"2028-12",{"name":605,"class":45},"Kaplan Medical Center",5,{"id":608,"slug":609,"hasResults":11,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":108,"sex":109,"minAge":4,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":617,"conditions":618,"keywords":623,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":46},"100583650","maternal-iron-deficiency-and-childhood-health-100583650","NCT06879080","Maternal Iron Deficiency and Childhood Health","Maternal Iron Deficiency and Childhood Health- a Prospective Cohort Study","MATILDA","Inclusion Criteria:\n\n* Pregnant\n* Can read and write Finnish, Swedish or English\n\nExclusion Criteria:\n\n* Illiterate",{"count":616,"type":20},6000,"The aim of this prospective observational cohort study is to study maternal iron deficiency and iron deficiency anemia and the use of iron supplements in pregnancy and their impact on the health of the offspring and pregnancy outcomes.\n\nAll women coming to Tampere University Hospital for prenatal checkups and\u002For labor are recruited to the study. After giving their consent the mothers fill an online questionnaire about about possible maternal anemia and its diagnosis in pregnancy, iron deficiency and its diagnosis in pregnancy, maternal use of iron supplement or folic acid and it´s timing, about possible other chronic disease and their medications during pregnancy, and whether the mother has got intravenous iron infusions in pregnancy. Mothers also give their permit to use their in-and outpatient data from pregnancy until hospital discharge and to follow the health of their offspring from birth until 7 years of age from in- and outpatient records.We aim to recruit 6000 mother-child-pairs.\n\nThe health of the offspring (growth, diagnoses, medication, possible therapies, need of support at daycare or school) will be followed for the first month, then at 1,5 years, four years and seven years of age from the patient records.\n\nIn addition to the cohort study, two nested cohort studies will be performed. The aim of the nested cohort studies is to study the correlation of maternal iron status to the iron status of the child. Secondary aim is to evaluate iron biomarkers, especially reticulocyte hemoglobin, and their reliability to interpret neonatal iron status.\n\nA 100 mothers with diagnosed iron deficiency and iron supplementation (p.o. or i.v.) in pregnancy, are recruited to Nested cohort 1. For the nested cohort 2, a 100 mothers with diabetes requiring insulin therapy in pregnancy are recruited. Tor these two cohorts, a 100 mothers without iron deficiency or diabetes will be recruited as controls. Iron status of the mother will be tested before delivery from blood sample. The iron status of the offspring will be checked from umbilical blood, at 2 days of age at the same time other lab tests are taken, at eight months and two and five years of age. In addition to the laboratory tests, parents fill up an electronical questionnaire at eight months, two and five years about the nutrition, sleep, behaviour and cognitive and motor skills of their child.\n\nThe researchers try to find out, whether iron deficiency in pregnancy has long-term effects on the health and development of the offspring, and how the iron status correlates between the mother and the child, and does it have impact on their sleep, behaviour or skills.",[619,26,620,621,622],"Iron Deficiency Anaemia in Childbirth","Iron Deficiency in Pregnancy","Iron Deficiency Anemia in Pregnancy","Iron Status",[624],"iron deficiency, iron deficiency anemia, pregnancy, pregnancy outcomes, health of the offspring","2025-03-11",{"date":627,"type":38},"2025-03-17",{"date":629,"type":38},"2024-04-22",{"date":631,"type":20},"2034-12-31",{"name":633,"class":45},"Tampere University Hospital",{"id":635,"slug":636,"hasResults":11,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":21,"phases":644,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":46},"100548926","phase-4-the-effects-of-low-dose-versus-high-dose-intravenous-iron-therapy-with-ferric-derisomaltose-in-patients-with-chronic-heart-failure-and-iron-deficiency-100548926","NCT06427343","The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency","The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)","IRONDOSE","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Left ventricular ejection fraction (LVEF) \\\u003C50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).\n3. New York Heart Association (NYHA) class II \\~ III.\n4. Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP \\>300 pg\u002FmL or BNP \\>100 pg\u002FmL. b. For patients in atrial fibrillation: NT-proBNP \\>600 pg\u002FmL or BNP \\>200 pg\u002FmL.\n5. Subjects with stable CHF (NYHA II\u002FIII functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics).\n6. Serum ferritin \\\u003C100 ng\u002FmL or serum ferritin 100-300 ng\u002FmL and TSAT \\\u003C20%.\n7. Able and willing to perform a CPET at the time of randomization.\n8. Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Hemoglobin \\\u003C9.0 g\u002FdL or Hemoglobin \\>15.0 g\u002FdL.\n2. Renal dialysis or MDRD\u002FCKD-EPI estimated glomerular filtration rate (eGFR) \\\u003C15 ml\u002Fmin\u002F1.73m2.\n3. Body weight \\\u003C35 kg.\n4. Heart failure was secondary to valvular diseases or congenital heart diseases.\n5. History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.\n6. Known hypersensitivity to ferric derisomaltose or other IV iron product.\n7. Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia.\n8. History of chronic liver disease and\u002For alanine transaminase (ALT) or aspartate transaminase (AST) \\>3 times the upper limit of the normal range; myelodysplastic disorder; and known HIV\u002FAIDS disease.\n9. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months prior to randomization.\n10. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) within 3 months prior to randomization; or planning cardiac surgery or revascularization.\n11. Already receiving erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days prior to randomization.\n12. Use of concurrent immunosuppressive therapy\n13. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate \\>100 beats\u002Fmin at rest), or uncontrolled hypertension with blood pressure \\>160\u002F100 mm Hg.\n14. Investigator considers a possible alternative diagnosis to account for the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease.\n15. Pregnancy or breast feeding.\n16. Participation in another intervention study involving a drug or device within the past 90 days.",{"count":643,"type":20},114,[277],"This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.",[358,26],[640],"2025-02-15",{"date":650,"type":38},"2025-02-19",{"date":652,"type":38},"2023-10-01",{"date":654,"type":20},"2026-12-21",{"name":656,"class":45},"China-Japan Friendship Hospital",{"id":658,"slug":659,"hasResults":11,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":108,"sex":109,"minAge":17,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":21,"phases":667,"briefSummary":668,"conditions":669,"keywords":671,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":46},"100577460","how-does-perimenopausal-menorrhagia-affect-womens-quality-of-life-and-cognitive-function-100577460","NCT06798584","How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?","Rough Journey to Menopause: How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?","MENO","Inclusion Criteria:\n\n* Undergoing natural perimenopause\n* English-speaking\n* In general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition\n\nExclusion Criteria:\n\n* Taking psychoactive drugs\n* A history of hematological disorders",{"count":666,"type":20},240,[23],"The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are:\n\n* What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women?\n* How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women?\n\nThe investigators will compare the effect of iron supplements to a placebo (gelatin capsule) to see if iron supplements could improve iron status, cognitive function, mood, quality of family relationships, and quality of life of iron-deficient and\u002For anemic women undergoing the menopausal transition.\n\nEach participant will:\n\n* Make 2 visits (about 2 hours each - baseline and endline) to the Clinical Research Center at Purdue\n* Make a very brief visit at midpoint (about 10 minutes) for a checkup\n* Take a daily study supplement or placebo for 4 months",[670,26,499],"Iron Deficiency Anemia Treatment",[119,672,64,26,673,674,675,676,677,678,679,680,681],"Perimenopause","Cognitive Function","Quality of Life","Mood","Quality of Family Relationships","Menopause","Perimenopausal Menorrhagia","Abnormal Uterine Bleeding","Menopause Transition","Women's Health","2025-02-12",{"date":684,"type":38},"2025-02-13",{"date":686,"type":20},"2025-03-01",{"date":688,"type":20},"2025-12",{"name":690,"class":45},"Purdue University",{"id":692,"slug":693,"hasResults":11,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":697,"eligibilityCriteria":698,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":699,"targetDuration":4,"studyType":21,"phases":701,"briefSummary":702,"conditions":703,"keywords":705,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":715,"locationsCount":717},"100456223","phase-2-effects-of-intravenous-administered-iron-in-non-anemic-iron-deficient-patients-with-colorectal-cancer-100456223","NCT05220800","Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer","Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer: A Double Blinded Clinical Randomized Trial","NAIDIC","Inclusion Criteria:\n\n* Planned for curative intended elective colon or rectum cancer surgery\n* UICC stage I-III (at diagnosis)\n* Hemoglobin \\> 7.0 mmol\u002FL\n* Serum ferritin \\\u003C101 microgram\u002FL or transferrin saturation \\\u003C21%\n\nExclusion Criteria:\n\n* Chronic kidney failure with need for dialysis\n* Metachronous diagnosed cancer\n* Unable to speak or understand Danish\n* Cognitive impairment e.g. moderate to severe dementia\n* Concurrent severe active bacterial infection\n* Known allergy for Iron(III)isomaltoside\n* Contraindications for intravenous iron (Pofryria, livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)\n* Withdrawal of informed consent\n* Neoadjuvant chemo or radiation therapy\n* Pregnancy",{"count":700,"type":20},134,[59],"This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study.\n\nStudy outline:\n\nAfter initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel",[63,704],"Colorectal Cancer",[706,63,707,530],"surgery","Colorectal cancer","2022-02-14",{"date":710,"type":38},"2022-03-03",{"date":712,"type":20},"2022-03-01",{"date":714,"type":20},"2029-03-01",{"name":716,"class":45},"Zealand University Hospital",3]