[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iron-deficiencies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iron-deficiencies":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,49,79,104,126,167,197,220,262,287,319,343,365,387,410,439],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100519373","kids-with-iron-deficiency-and-scoliosis-100519373",false,"NCT06042699","Kids With Iron Deficiency and Scoliosis","Kids With Iron Deficiency and Scoliosis (KIDS) Study","KIDS","Inclusion Criteria:\n\n1. 10-26 years old;\n2. diagnosis of scoliosis or kyphosis;\n3. self-reported ability to swallow a tablet;\n4. spinal fusion procedure planned approximately 6 to 24 weeks from an orthopedic surgical clinic visit at which patient agrees to phlebotomy for screening blood work;\n5. serum ferritin less than or equal to 25 µg\u002FL.\n\nExclusion Criteria:\n\n1. taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;\n2. taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;\n3. Hg \\\u003C10mg\u002FdL if post-menarchal, Hg \\\u003C 11 if premenarchal or male\n4. C-reactive protein \\> 10 mg\u002FL\n5. receiving nutritional support by report in the medical chart;\n6. self-reported history of hypersensitivity reaction to iron-containing supplements;\n7. self-reported history of or suspected non-iron deficient hematologic disorder;\n8. self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis;\n9. objection to receiving red blood cell transfusions;\n10. current pregnancy (by self-report);\n11. prisoners;\n12. patient or parent decides against study participation.",true,"ALL","10 Years","26 Years",{"count":22,"type":23},275,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study is a randomized controlled trial of preoperative oral 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 adolescents undergoing scoliosis surgery.\n\nResearch Question(s)\u002FHypothesis(es):\n\nPrimary\n\n* Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion.\n\nSecondary\n\n* Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion.\n* Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.",[29,30,31,32,33,34,35],"Adolescent Idiopathic Scoliosis","Neuromuscular Scoliosis","Perioperative\u002FPostoperative Complications","Iron Deficiencies","Anemia","Spinal Fusion","Postoperative Cognitive Dysfunction","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-26","ACTUAL",{"date":42,"type":40},"2024-01-11",{"date":44,"type":23},"2028-02-01",{"name":46,"class":47},"Columbia University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100642082","early-phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ctx001-in-healthy-adults-100642082","NCT07577817","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.","A Phase 1, 3-Part, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of CTX001 in Healthy Adult Participants.","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Agrees to use effective contraception\n* Body Mass Index (BMI) between 18.0 and 32.0 kg\u002Fm2\n* Healthy by medical evaluation and medical history\n* Hematological parameters, serum iron, transferrin and ferritin are within normal range and transferrin saturation is within normal range and greater than or equal to 20%\n* Can swallow tablets and has suitable venous access for blood sampling\n\nExclusion Criteria:\n\n* Has dietary requirements that may be difficult to accommodate\n* Is a regular user of cannabis or has a history of illicit drug abuse within 1 year\n* Has a history of alcohol abuse or binge drinking within 6 months\n* Is a regular user of tobacco or nicotine-containing products\n* Unwilling or unable to comply with the lifestyle guidelines described in the protocol\n* Has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator\n* Has any concurrent disease or condition or physical, psychological, mental, and\u002For social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study\n* Has received a blood transfusion within 1 year\n* Has donated whole blood within 6 months or plasma within 30 days\n* Requires prescription medication or regular use of non-prescription medication\n* Is an employee of the Sponsor, the CRO, or of any organization or site(s) associated with this study, or any immediate family member who is in a dependent relationship with a study site employee who is involved in the conduct of the study","18 Years","55 Years",{"count":59,"type":23},72,[61],"EARLY_PHASE1","This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly. The purpose of this study is to investigate any side effects that may happen with CTX001, how CTX001 is absorbed by and processed in the body, and how CTX001 affects iron levels in the blood when administered with or without iron and\u002For food.",[33,32,64],"Chronic Kidney Disease",[66,67,33,68],"Red blood cells","Iron","Chronic kidney disease","2026-06-10",{"date":71,"type":40},"2026-06-12",{"date":73,"type":23},"2026-06",{"date":75,"type":23},"2026-12-30",{"name":77,"class":78},"Cajal Therapeutics Inc.","INDUSTRY",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":18,"minAge":86,"maxAge":56,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":48},"100636276","efficacy-of-oral-sucrosomial-iron-supplementation-in-children-with-celiac-disease-and-iron-deficiency-or-anemia-100636276","NCT07563582","Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia","Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of CD according to the current European ESPGHAN guidelines (clinical or histological) with confirmed hypoferritinemia or iron deficiency anemia.\n2. Age at diagnosis of CD between 8 and 18 years (inclusive).\n3. Absence of oral martial supplementation in the 30 days before the diagnosis and intravenous martial supplementation in the 90 days prior to the diagnosis of CD.\n4. Patients who have not already started GFD before diagnosis.\n5. Exclusion of other causes of anemia.\n6. Patients (and parents\u002Flegal guardian) able to understand and willing to participate in the study, with collaborative attitude.\n7. Informed consent release by both parents\u002Flegal guardian.\n\nExclusion Criteria:\n\n1. Potential celiac disease.\n2. Hb \\\u003C 8 g\u002FdL at screening\n3. Other causes of anemia, hemoglobinopathies or coagulopathies.\n4. Active bleeding or surgery or major trauma in the last 6 months.\n5. Other inflammatory diseases, neoplasms or IgE mediated food allergies\n6. Syndromes or presence of vascular malformations\n7. Pregnant or lactating patients (based on self-certification by the parents and by the patient, where applicable)\\*\n8. Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.\n9. Taking oral iron-based medications in the 30 days prior to diagnosis and intravenous iron-based medications in the 90 days prior to diagnosis.\n10. Use of other investigational drug(s) within 30 days before study entry or during the study.\n11. Any other condition, illness or treatment that in the Investigator's opinion does not make the patient suitable for the study.\n\n    * Self-certification of non-pregnancy status is considered sufficient given that the product under study is a safe and well-tolerated dietary supplement that has already been tested in pregnant women.","8 Years",{"count":88,"type":23},60,[26],"Celiac disease in children is frequently associated with iron deficiency and\u002For iron deficiency anemia due to intestinal malabsorption and chronic inflammation. Although a gluten-free diet is the standard treatment and can restore iron balance over time, there is currently no clear evidence or consensus on the role and timing of iron supplementation in pediatric patients at diagnosis.\n\nGiven the potential impact of anemia on growth and neurodevelopment, strategies that enable a faster correction of iron deficiency are clinically relevant. Sucrosomial® iron has shown improved absorption and gastrointestinal tolerability compared to conventional oral iron in adult celiac patients.\n\nThis study aims to evaluate whether Sucrosomial® iron supplementation, in addition to a gluten-free diet, is more effective and safe than diet alone in achieving a faster normalization of hemoglobin and iron stores in children with newly diagnosed celiac disease.\n\nThe primary objective of this randomized, double-blind, placebo-controlled, parallel-group study is to assess whether oral supplementation with Sucrosomial® iron, when added to a gluten-free diet (GFD), accelerates the normalization of iron stores and hemoglobin levels compared with GFD alone in school-age children and adolescents newly diagnosed with celiac disease presenting with hypoferritinemia and\u002For iron deficiency anemia.\n\nTarget Study Population: Children and adolescents with celiac disease and iron deficiency or anemia due to iron deficiency.\n\nStudy Duration Total study duration (per patient) will be about 6 months; total treatment duration (per patient) will be 6 months.\n\nNumber of Patients: 60 planned Two typologies of patients will be included: with hypoferritinemia and with anemia due to iron deficiency.\n\nThe randomization process will be stratified, so that:\n\n* 15 patients with hypoferritinemia receive active treatment and 15 patients receive placebo;\n* 15 patients with anemia due to iron deficiency receive active treatment and 15 patients receive placebo.\n\nThe age of patients will also be considered for the randomization (to assign the correct number of product bottles).",[92,33,32],"Celiac Disease in Children",[94],"Iron deficiency\u002Fanemia due to iron deficiency in CD children and adolescents","2026-04-29",{"date":97,"type":40},"2026-05-04",{"date":99,"type":40},"2025-12-23",{"date":101,"type":23},"2027-09",{"name":103,"class":47},"Istituto Giannina Gaslini",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":17,"sex":110,"minAge":56,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":123,"locationsCount":48},"100586001","influences-of-long-acting-reversible-contraceptives-on-iron-status-and-physiological-responses-to-extreme-environments-in-women-100586001","NCT06909695","Influences of Long-acting Reversible Contraceptives on Iron Status and Physiological Responses to Extreme Environments in Women","Inclusion Criteria:\n\n* • Females, age 18-40 y\n\n  * Females taking monophasic oral contraceptives or utilizing implantable contraception (intrauterine device, implantable bar) for at least one year, and be at least one year removed from the removal end point (e.g. before year 4 for a 5-year IUD)\n  * In good health as determined by OMSO (Office of Medical Support and Oversight)\n  * Passed most recent Army Combat Fitness Test (ACFT) (military volunteers only) or exercise at least 2 times per week (civilian volunteers)\n  * Willing to not drink alcoholic beverages for 24 hours before each testing session\n  * Willing to not consume caffeine 12 hours prior to any testing sessions\n  * Willing to refrain from any exercise and additional moderate to strenuous physical activity 24 hours prior to testing\n  * Willing to stay and exercise in an altitude chamber (the size of a dorm room) for \\~6 hours\n  * Supervisor approval for federal civilian employees and non-HRV active-duty military personnel stationed at NSSC.\n\nExclusion Criteria:\n\n* • Females who are pregnant, planning to become pregnant during the study, or breastfeeding.\n\n  * Taking prescription, over the counter medication, or dietary supplements, other than a contraceptive (unless approved by OMSO and Principal Investigator (PI))\n  * Tobacco or nicotine users, or anyone who has used tobacco or nicotine within the last four months\n  * Physical problems\u002Finjuries (e.g., current stress fractures, musculoskeletal strains) that would affect walking or running on a treadmill\n  * Allergy to skin adhesive\n  * Heart, lung, kidney, muscle, endocrine, or nerve disorder(s) as determined by OMSO\n  * History of heat intolerance or orthostatic intolerance\n  * Diagnosed and\u002For treated for fluid\u002Felectrolyte imbalance within the last 30 days\n  * History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis.\n  * Scheduled MRI within 2 weeks after completing a heat or cold test\n  * Actively dieting with the intent to lose weight\n  * History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains).\n  * Raynaud's syndrome\n  * Cold-induced asthma\u002Fbronchospasm\n  * Not willing to have small areas of skin on the body shaved (if deemed necessary for attachment of study instrumentation)\n  * Born at altitudes greater than 2,100 m (7,000 ft) (e.g., Mexico City, Mexico)\n  * Living in areas that are more than 1,200 m (4,000 ft) (e.g., Colorado Springs, CO) or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months\n  * Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)\n  * Abnormal blood count in accordance with OMSO - Normal Hb women: 11.1-15.9 g·dL-1 or Normal Hct women: 34.0-48%, or presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)\n  * History of pneumothorax\n  * History of hypertension\n  * Blood donation within 8 weeks of beginning the study\n  * Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)\n  * Evidence of apnea or sleeping disorder (narcolepsy, insomnia, etc.)","FEMALE","40 Years",{"count":113,"type":23},33,"OBSERVATIONAL","Over recent years, military service women have shown increasing interest in utilizing long-acting reversible contraceptives (LARCs; i.e., implants or intrauterine devices, IUDs). While clinically, LARC have been proven safe and effective at preventing pregnancy \\& decreasing menstrual symptoms, it is unclear what impact this type of contraceptive may have on physiological responses to extreme environments (heat, cold and high altitude). Additionally, iron deficiency and iron deficiency anemia are prevalent in U.S. military women which likely affect health and performance. There is evidence to suggest that the prevalence of iron deficiency and iron deficiency anemia is lower in women utilizing LARCs, which preserve iron stores, likely due to reduced menstrual blood loss that compounds with each cycle over the course of months. Due to the increasing interest in the utilization of LARCs it is important to understand what, if any, impact these methods of contraception may have on a female Soldier's physiological responses.\n\nThe overall goal of the present study is to characterize iron status and physiological responses (including but not limited to sweating, skin blood flow, ventilation, and heart rate) to extreme environmental stressors of heat, cold and high altitude (i.e. hypobaric hypoxia) in women utilizing LARCs. Up to thirty-three individuals (n=18 LARCs, n=15 monophasic oral contraceptives) will complete testing visits separated by at least 48 hours for environmental testing visits. During heat stress testing, measures of core body temperature, skin temperature, and sweat rate will be measured during a standardized protocol in hot, humid conditions. During cold stress, measures of body core temperature, metabolic heat production, skin blood flow and temperature (at both distal extremity and proximal body sites) will be assessed in order to better quantify the impact of exogenous sex hormones via LARCs and OCs in volunteers exposed to the cold. Measurements will be obtained during a standardized protocol in cold air (\\~90 min; 10°C). For altitude, cardiopulmonary responses will be assessed during rest and exercise during an acute altitude exposure (4300m). Blood samples will be collected throughout the investigation in order to quantify sex hormone concentrations, iron status, and inflammatory biomarkers in response to environmental stressors. The investigators will also utilize laboratory tests (i.e., carbon monoxide (CO) rebreathing technique) and collect blood samples to quantity iron stores in these groups of women. To characterize iron status, the Soldier Performance Health and Readiness (SPHERE) epidemiological data repository will be utilized to quantify the prevalence of iron deficiency and iron deficient anemia diagnoses between women using LARCs and women not utilizing LARCs.",[117,32],"Contraception",{"date":119,"type":40},"2026-04-30",{"date":121,"type":40},"2024-11-01",{"date":101,"type":23},{"name":124,"class":125},"United States Army Research Institute of Environmental Medicine","FED",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":17,"sex":110,"minAge":56,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":24,"phases":137,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":48},"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":136,"type":23},30,[26],"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.",[32,140,141,142],"Low Ferritin","Iron Deficiency","Exercise Performance of Fit Athletes",[144,145,146,147,148,149,150,151,152,153,154,155,156,157,158],"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":161,"type":40},"2026-04-27",{"date":119,"type":23},{"date":164,"type":23},"2027-04-30",{"name":166,"class":47},"Lindenwood University",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":110,"minAge":56,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":24,"phases":176,"briefSummary":178,"conditions":179,"keywords":183,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":48},"100635749","phase-3-comparison-of-ferrous-salt-vs-liposomal-iron-in-adult-women-with-iron-deficiency-anemia-100635749","NCT07556731","Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia","IDA","Inclusion Criteria:\n\n* Female patients of reproductive age (15 to 49 years) with a diagnosis of iron-deficiency anemia secondary to dysfunctional uterine bleeding.\n* Patients with iron-deficiency anemia who are treatment-naïve or whose last administration of iron therapy, either oral or parenteral, occurred at least three months prior to enrollment and who continue to have anemia.\n* Patients with a functional oral route.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with abnormal uterine bleeding secondary to cancer\n* Severe intolerance to iron supplementation\n* Patients with gastritis or chronic use of proton pump inhibitors\n* Concomitant treatment with dietary supplements rich in calcium, magnesium, or zinc\n* Patients with endocrine disorders (hypothyroidism, hyperthyroidism)\n* Uncontrolled type 2 diabetes mellitus\n* Associated gastrointestinal bleeding\n* Patients with esophageal disorders",{"count":175,"type":23},100,[177],"PHASE3","The goal of this study is to compare ferrous salt and liposomal iron for the treatment of iron-deficiency anemia in adult women. The study will also evaluate how well each treatment is tolerated.\n\nThe main questions this study aims to answer are:\n\nDoes liposomal iron increase hemoglobin levels as effectively as ferrous salt?\n\nAre there differences in side effects, especially gastrointestinal symptoms, between the treatments?\n\nDoes dosing ferrous salt every other day improve tolerance compared to daily dosing?\n\nResearchers will compare three oral iron treatment strategies to determine which approach provides the best balance between effectiveness and tolerability.\n\nParticipants will:\n\nBe adult women diagnosed with iron-deficiency anemia\n\nBe randomly assigned to one of three groups:\n\nDaily ferrous salt Ferrous salt taken every other day Daily liposomal iron Take the assigned iron treatment for 3 months Have blood tests at the beginning and end of the study to measure hemoglobin and iron levels Report any side effects or intolerance during treatment",[180,181,32,182],"Iron-deficiency Anemia (IDA)","Hemoglobin","Adverse Effect",[184,185,186,187,148],"Iron-deficiency anemia treatment comparision","Oral iron dosing","Liposomal iron","Iron replacement therapy","NOT_YET_RECRUITING",{"date":95,"type":40},{"date":191,"type":23},"2026-05-01",{"date":193,"type":23},"2027-07-01",{"name":195,"class":196},"Hospital General de Mexico","OTHER_GOV",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":24,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":48},"100590555","long-term-outcomes-sub-study-of-preoperative-combined-iron-therapy-100590555","NCT06968936","Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy","Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Participants must be at least 18 years of age.\n2. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.\n3. Iron deficiency anemia is defined as having a ferritin level below 100 μg\u002FL or a ferritin level below 300 μg\u002FL accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g\u002FL for men or between 90 and 120 g\u002FL for women.\n4. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.\n5. Prior to participation, the patient or their legal representative must provide informed consent.\n\nExclusion Criteria:\n\n1. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.\n2. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.\n3. Individuals with a weight equal to or less than 50kg.\n4. Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload.\n5. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.\n6. Requirement for emergency surgical intervention.\n7. Severe hepatic or renal impairment, ALT \\>3 times the upper limit of normal value or AST \\>3 times the upper limit of normal value, creatinine \\>1.5 times the upper limit of normal value\n8. Pregnant or lactating women\n9. history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery\n10. Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.","85 Years",{"count":206,"type":23},400,[26],"This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.",[33,32,210],"Cardiac Surgery","2026-04-07",{"date":213,"type":40},"2026-04-13",{"date":215,"type":40},"2026-03-27",{"date":217,"type":23},"2029-06-30",{"name":219,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":18,"minAge":228,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":24,"phases":231,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":261},"100629606","phase-4-effect-of-intravenous-iron-on-quality-of-life-in-older-patients-with-acute-coronary-syndrome-100629606","NCT07476859","Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome","Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome","HI-COR-65","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.\n3. Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as:\n\n   * Serum ferritin \\\u003C 100 ng\u002FmL, OR\n   * Transferrin saturation (TSAT) \\\u003C 20%.\n4. Ability to provide written informed consent prior to participation.\n\nExclusion Criteria:\n\n1. Active malignancy.\n2. End-stage or terminal illness as determined by the IDC-Pal score.\n3. Known heart failure with left ventricular ejection fraction (LVEF) \\\u003C 40% prior to enrollment, or development of LVEF \\\u003C 40% during hospitalization or within 15 days after ACS.\n4. Chronic dialysis or advanced renal or hepatic failure.\n5. Severe anemia (hemoglobin \\\u003C 10 g\u002FdL) at the time of ACS or within 15 days after the event.\n6. Prior treatment with intravenous or oral iron within 12 months before the index ACS.\n7. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.\n8. Evidence of iron overload or disorders of iron metabolism.\n9. Ongoing bacteremia or active systemic infection.\n10. Participation in another interventional clinical trial involving an investigational medicinal product.\n11. Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.","65 Years",{"count":230,"type":23},538,[232],"PHASE4","The goal of this phase IV, open-label, randomized clinical trial is to evaluate whether intravenous iron improves quality of life in adults aged 65 years and older with iron deficiency after an acute coronary syndrome (ACS).\n\nThe main questions it aims to answer are:\n\n* Does intravenous iron improve quality of life at 6 and 12 months?\n* Does it reduce frailty and adverse clinical outcomes?\n\nResearchers will compare intravenous ferric carboxymaltose with standard of care.\n\nParticipants will:\n\n* Be randomly assigned to receive intravenous iron or standard care\n* Attend three study visits over 12 months\n* Complete questionnaires and undergo blood tests",[235,32,236],"Acute Coronary Syndromes (ACS)","Elderly (People Aged 65 or More)",[238,239,240,241,242,243,244,245,246,247,248,249,250,251],"Acute coronary syndrome","Iron deficiency","Intravenous iron","Ferric carboxymaltose","Quality of life","Older adults","Myocardial infarction","Frailty","Cardiovascular outcomes","Biological aging","ELOVL2 methylation","Telomere length","Klotho","FGF23","2026-03-20",{"date":254,"type":40},"2026-03-24",{"date":256,"type":40},"2026-03-05",{"date":258,"type":23},"2028-05",{"name":260,"class":47},"Fundación para la Investigación del Hospital Clínico de Valencia",9,{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":18,"minAge":268,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":24,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":4},"100578840","the-effects-of-iron-treatment-on-malaria-and-measles-vaccine-response-in-kenyan-infants-with-iron-deficiency-100578840","NCT06816524","The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron Deficiency","Inclusion Criteria:\n\n* Subject's caregiver is willing and able to give informed consent\n* Male or Female, 6 months (+\u002F- 2 weeks) of age\n* Mother at least ≥15 years of age\n* Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \\>61 μmol\u002Fmol heme)\n* With or without anemia (anemia defined by Hb \\\u003C110 g\u002FL)\n\nExclusion Criteria:\n\n* Severely anemic (Hb \\\u003C70 g\u002FL)\n* Malaria vaccination prior to enrollment\n* Medical condition that precludes study involvement\n* Iron supplementation 2 weeks before enrollment\n* Acute or chronic infection (e.g. HIV)\n* Wasted (length for height z score of ≥-2) or underweight (weight for age z score ≥-2).","6 Months",{"count":270,"type":23},324,[26],"Malaria and iron deficiency cause a significant burden of disease in Africa. Iron deficiency (ID) might affect immune responses to vaccination.\n\nIn this double-blind randomized controlled trial, we aim to assess: (1) whether ID impairs R21\u002FMatrix-M and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.",[32],[239,275,276,277],"Vaccine immunogenicity","Malaria","Measles","2025-12-19",{"date":280,"type":40},"2025-12-26",{"date":282,"type":23},"2026-01-05",{"date":284,"type":23},"2028-04-30",{"name":286,"class":47},"Nicole Stoffel",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":17,"sex":18,"minAge":295,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":299,"briefSummary":300,"conditions":301,"keywords":305,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100617182","maximizing-the-benefits-of-iron-in-ready-to-use-therapeutic-foods-for-malnourished-children-in-kenya-100617182","NCT07315295","Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya","Maximizing the Benefits of Iron in Ready-to-use Therapeutic Foods for Malnourished Children in Kenya","SAMI","Inclusion Criteria:\n\nmalnourished children:\n\n* severe acute malnutrition (SAM): WHZ \\\u003C -3.0\n* moderate acute malnutrition (MAM): WHZ \\\u003C -2.0 a\n* treated as outpatients (no acute medical conditions and a positive appetite test)\n\nhealthy children:\n\n\\- healthy: HAZ, WAZ and WHZ = 0\n\nExclusion Criteria (both groups):\n\n* Hemoglobin ≤7 g\u002FdL\n* Presence of acute medical conditions requiring inpatient management","12 Months","54 Months",{"count":298,"type":23},68,[26],"Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia. The current RUTF formulation may have an excessively high iron content. In severely acutely malnourished (SAM) children, iron cannot be properly absorbed, leading to life-threatening diarrhea. The overall aim of this project is to develop an improved RUTF treatment that addresses acute malnutrition and anemia in children, ensuring both safety and efficacy. Specifically, to assess the impact of malnutrition on fractional iron absorption (FIA) from RUTFs in children, by comparing healthy children to those with acute malnutrition and by tracking changes in FIA in malnourished children over the course of treatment.",[302,32,303,304,33],"Iron Absorption","Severly Acutely Malnourished Children","Malnutrition in Children",[306,307,308,309],"Ready to use therapeutic foods (RUFTs)","Severe acute malnutrition (SAM)","Stable isotopes","Iron bioavailability","2025-12-18",{"date":312,"type":40},"2026-01-02",{"date":99,"type":23},{"date":315,"type":23},"2026-06-30",{"name":317,"class":47},"ETH Zurich",2,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":18,"minAge":326,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":24,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":48},"100611314","phase-4-postoperative-intravenous-ferric-derisomaltose-for-prevention-of-long-term-anemia-after-cardiac-surgery-100611314","NCT07238972","Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery","Impact of Postoperative Intravenous Iron Supplementation on the Incidence of Long-term Anemia in Patients Undergoing Cardiac Surgery","Inclusion Criteria:\n\n* Adults aged ≥19 years scheduled to undergo cardiac surgery requiring cardiopulmonary bypass Preoperative anemia defined as hemoglobin \\\u003C13.0 g\u002FdL, or preoperative iron deficiency defined as ferritin \\\u003C100 ng\u002FmL or transferrin saturation \\\u003C20% Ability to understand the study information and provide written informed consent prior to surgery\n\nPostoperative day 1 hemoglobin \\\u003C10.0 g\u002FdL on the first CBC following surgery (required for final enrollment)\n\nExclusion Criteria:\n\n* Emergency surgery Preoperative major organ failure requiring intensive care unit management Active infection prior to surgery, including sepsis Active bleeding prior to surgery Pregnancy or breastfeeding Use of erythropoiesis-stimulating agents or intravenous iron therapy within 3 months prior to surgery Iron overload defined as ferritin ≥500 ng\u002FmL or transferrin saturation ≥45% Aplastic anemia Hemolytic anemia Hemochromatosis or hemosiderosis Decompensated liver cirrhosis, acute hepatitis, or alcohol dependence Known hypersensitivity to intravenous iron formulations Participation in another clinical trial that may influence outcomes Inability to understand or provide informed consent due to language barriers, illiteracy, or cognitive impairment","19 Years",{"count":328,"type":23},180,[232],"Postoperative anemia is highly prevalent among patients undergoing cardiac surgery and is associated with delayed functional recovery, increased morbidity, and impaired long-term outcomes. Preoperative iron deficiency is common in this population and contributes to inadequate erythropoietic recovery after surgery. Functional iron deficiency frequently develops even in patients without preoperative deficiency due to blood loss, hemodilution, and inflammation-mediated disruption of iron homeostasis. Despite this clinical burden, standardized strategies for postoperative anemia management have not been established.\n\nThis prospective, randomized, double-blind, placebo-controlled clinical trial evaluates whether early postoperative intravenous iron supplementation improves long-term anemia outcomes in patients undergoing cardiac surgery with cardiopulmonary bypass. Adult patients with preoperative anemia (hemoglobin \\\u003C13 g\u002FdL) or iron deficiency (ferritin \\\u003C100 ng\u002FmL or transferrin saturation \\\u003C20%) will be screened. Eligible participants with postoperative day (POD) 1 hemoglobin \\\u003C10 g\u002FdL will be randomized in a 1:1 ratio to receive either ferric derisomaltose (20 mg\u002Fkg, maximum 1,000 mg) or a matched placebo administered intravenously over 30 minutes on POD 1. All perioperative management outside the intervention follows current institutional standards.\n\nThe primary outcome is the incidence of anemia at 6 months following surgery. Secondary outcomes include perioperative hemoglobin trends, functional recovery assessed by cardiopulmonary exercise testing and the 6-minute walk test at 6 months, transfusion requirements, postoperative complications including MAKE-90 and STS major morbidity, and changes in biomarkers of erythropoiesis and iron metabolism (erythroferrone, erythropoietin, hepcidin, and iron profile). Blood samples for biomarker analysis are collected at predefined perioperative timepoints.\n\nFerric derisomaltose allows high-dose single-session iron repletion with a favorable safety profile and minimal risk of anaphylaxis when administered slowly. Prior studies in cardiac surgery and heart failure populations support its efficacy and safety at doses up to 20 mg\u002Fkg. The intervention is expected to facilitate erythropoietic recovery, reduce the duration of postoperative anemia, and improve long-term functional status. The trial aims to generate evidence to inform postoperative anemia management strategies in cardiac surgery patients.",[33,32,332,210,333],"Iron Deficiency Anemia","Heart Valve Diseases","2025-11-16",{"date":336,"type":40},"2025-11-20",{"date":338,"type":23},"2025-12",{"date":340,"type":23},"2030-10",{"name":342,"class":47},"Yonsei University",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":228,"enrollmentInfo":349,"targetDuration":4,"studyType":24,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":48},"100611146","study-on-supplement-of-intravenous-ferric-derisomaltose-to-prevent-anemia-and-improve-the-quality-of-life-in-obese-patients-with-iron-deficiency-100611146","NCT07236788","Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.","Inclusion Criteria:\n\n* ① Baseline Hb: Men 10-14 g\u002FdL, Women 10-13 g\u002FdL; ② Iron deficiency: Serum ferritin (SF) \\\u003C100 μg\u002FL, and transferrin saturation (TSAT) \\\u003C20%; ③ BMI \\>30 kg\u002Fm2.\n\nExclusion Criteria:\n\n* ① Known severe hypersensitivity reactions to other parenteral iron supplements; ② Mean corpuscular volume (MCV) \\> 100 fL; ③ Received intravenous iron infusion within the past 3 months; ④ Concurrent tumors; ⑤ Concurrent iron overload or other hematologic disorders; ⑥ Concurrent infectious diseases such as hepatitis B; ⑦ Moderately impaired liver function: decompensated cirrhosis or hepatitis, ALT, AST \\> 3 × upper limit of normal (ULN); ⑧ Concurrent acute or chronic infections, heart failure, or other diseases affecting iron metabolism; ⑨ Patients with stage 3 or higher chronic renal insufficiency: glomerular filtration rate (eGFR) \\\u003C 60 ml\u002Fmin; ⑩ Pregnant or lactating women; ⑪ Acute infections, rheumatoid arthritis, or significant joint inflammation.",{"count":350,"type":23},200,[26],"This study aimed to explore the effects of preoperative intravenous isomaltose iron supplementation versus placebo on postoperative Hb improvement, prevention of postoperative anemia, and improvement in quality of life in patients undergoing bariatric surgery.",[354,33,32,355],"Obesity","Bariatric Surgery","2025-11-15",{"date":358,"type":40},"2025-11-19",{"date":360,"type":40},"2025-03-01",{"date":362,"type":23},"2027-03-30",{"name":364,"class":47},"China-Japan Friendship Hospital",{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":24,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":385,"locationsCount":48},"100604977","impact-of-two-iron-formulations-on-iron-biomarkers-and-quality-of-life-100604977","NCT07156526","Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life","Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Randomized, Double-Blind Pilot Study","Inclusion Criteria:\n\n* Provide voluntary, written, informed consent to participate in the study\n* Agree to provide a valid cell phone number and are willing to receive communications through text\n* Can read and write English\n* Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly\n* Willing to complete questionnaires, records, and diaries associated with the study.\n* If the participant responded \"Yes\" to ≥2 questions on the custom Iron Inadequacy Questionnaire. Preference will be given to participants with a higher score.\n* If a participant has the following:\n\nFerritin 30 ng\u002FmL (anything under 50 ng\u002FmL is considered suboptimal, but participants with 30 ng\u002FmL will be prioritized)\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial\n* Known food intolerances\u002Fallergy to any ingredients in the product\n* Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, irritable bowel disease, cancer\n* Having had a significant cardiovascular event in the past 6 months\n* Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines\n* On immunosuppressive therapy\n* Individuals who were deemed incompatible with the test protocol\n* Adults lacking capacity to consent\n* Individuals taking any of the following medications:\n\nAntacids Proton pump inhibitors (PPIs) Antipsychotics Antibiotics",{"count":373,"type":23},40,[26],"This randomized, double-blind parallel pilot study will evaluate the safety and efficacy of two Qualia Iron formulations versus placebo in approximately 40 healthy adults (aged 18+) over a 56-day period. Approximately 40 participants will be randomized to three study arms: Qualia Iron Version 1, 2, (n=15 each) or a Placebo (n=10). Each participant will take one or two capsules once daily in the morning, with or without food. The supplementation regimen is a 5 days on, 2 days off protocol, and goes for 56 days (8 weeks). The primary outcomes of this study are to assess between-group changes in iron status biomarkers. Secondary outcomes include within-group changes in iron status biomarkers, safety and tolerability as measured by a custom Safety and Tolerability survey, and RAND SF-36 quality of life scores.",[32],[378,239],"Iron supplementation","2025-08-27",{"date":381,"type":40},"2025-09-05",{"date":383,"type":23},"2025-09-10",{"date":356,"type":23},{"name":386,"class":78},"Qualia Life Sciences",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":24,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":48},"100587547","phase-3-multi-center-trial-of-ferric-derisomaltose-versus-no-intravenous-iron-in-iron-deficient-subjects-with-symptomatic-chronic-heart-failure-100587547","NCT06929806","Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure","A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure","ICONIC-HF","Inclusion Criteria:\n\n* 18 years or older\n* Both women and men can join\n* Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity\n* Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less\n* Have low iron levels in the blood\n* New York Heart Association (NYHA) Heart Failure Classification II, III or IV\n\nExclusion Criteria:\n\n* Planned cardiac surgery or revascularization or cardiac device implantation\n* Pregnant or nursing women\n* Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months\n* Treatment with radiotherapy or chemotherapy",{"count":396,"type":23},1900,[177],"The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is:\n\n• How many participants are admitted to the hospital or die from a disease in the heart or blood vessels\n\nResearchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works.\n\nParticipants will:\n\n* Be randomized 50\u002F50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose\n* All participants receives standard of care\n* Visit site 4-5 times and have 7 video\u002Fphone-calls",[400,32],"Chronic Heart Failure","2025-07-17",{"date":403,"type":40},"2025-07-23",{"date":405,"type":40},"2025-05-01",{"date":407,"type":23},"2027-12-01",{"name":409,"class":78},"Pharmacosmos A\u002FS",{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":48},"100557800","ironheart-intravenous-iron-in-non-ischaemic-heart-failure-100557800","NCT06542822","IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure","Immediate Effects of Intravenous Iron Therapy in Patients With Systolic Heart Failure and Iron Deficiency as Evaluated by Cardiac Magnetic Resonance Imaging: An Observational Prospective Study","IRONHEART","Inclusion Criteria:\n\n* Participants capable of giving informed consent.\n* Aged 18yrs and above.\n* Diagnosed with heart failure and a reduction of their ejection fraction \\\u003C 40% by any modality.\n* Non ischaemic cardiomyopathy as determined by baseline cardiac magnetic resonance imaging.\n* Iron deficient per this definition: Transferrin saturations \\\u003C 20%.\n* Established on Heart failure therapy including SGLT2i therapy for a minimum of four weeks prior to recruitment.\n* New York Heart Association score of I - III class.\n\nExclusion Criteria:\n\n* New York Heart Association classification Score \\>IV\n* Ischaemic cardiomyopathy\n* Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30\n* Requirement for renal dialysis\n* Atrial fibrillation \u002F atrial flutter\n* Non cardiac and cardiac palliative diagnosis\n* Active cancer diagnosis\n* Moderate to severe valvular heart disease\n* Cardiac electronic implantable device: Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, left ventricular assist device\n* Cardiac \\& non cardiac transplant participants\n* Myocardial infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft surgery in the last 30 days\n* Complex congenital heart disease\n* Pregnancy",{"count":5,"type":23},"The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure (LVEF\\\u003C40%), iron deficiency (TSATS\\\u003C20%) and established on heart failure therapy including Sodium-glucose cotransporter 2 inhibitors (SGLT2i). Participants will undergo baseline laboratory blood tests, cardiac magnetic resonance imaging (cMRI), six-minute walk test, musculoskeletal function test and Kansas City Cardiomyopathy Questionnaire (KCCQ). These investigations will be repeated at 24 hours and 30 days after the administration of intravenous ferric derisomaltose.",[421,32],"Heart Failure",[423,424,425,239,426,427,428,429],"Ferric derisomaltose","Non-ischaemic heart failure","Chronic heart failure","Left ventricular failure","Iron homeostasis","Cardiac MRI","Cardiac Magnetic resonance imaging","2024-08-05",{"date":432,"type":40},"2024-08-07",{"date":434,"type":40},"2024-04-15",{"date":436,"type":23},"2027-02",{"name":438,"class":47},"University Hospital Southampton NHS Foundation Trust",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":449,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":48},"100549438","phase-3-iv-iron-and-sglt2-inhibitor-on-ventricular-function-and-myocardial-iron-content-in-heart-failure-with-iron-deficiency-100549438","NCT06434025","IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency","Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.","COMBINED-HF","Inclusion Criteria:\n\n1. Age 18 years or over;\n2. Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography;\n3. Serum ferritin \\\u003C100 µg\u002FL or serum ferritin between 100 and 299 µg\u002FL and transferrin saturation \\\u003C20%;\n4. Serum hemoglobin between 9.5 and 13.5 mg\u002FdL;\n5. Patients must be SGLT2 naive;\n6. Informed consent form (ICF) signed.\n\nExclusion Criteria:\n\n1. Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular ﬁltration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;\n2. Severe primary valve disease;\n3. Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;\n4. Patients already being treated for some type of non-iron deﬁciency anemia;\n5. Blood transfusion within 30 days prior to CMR examination;\n6. Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;\n7. Diagnosis of hemochromatosis.",{"count":448,"type":23},99,[177],"Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deﬁciency. However, the mechanisms underlying these beneﬁcial eﬀects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content.\n\nThis study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deﬁciency.",[452,32],"Heart Failure, Systolic",[454,455,456,457,458],"heart failure","iron deficiency","SGLT2 inhibitor","intravenous iron","clinical trial","2024-05-30",{"date":461,"type":40},"2024-06-03",{"date":463,"type":23},"2024-05-24",{"date":465,"type":23},"2026-11-24",{"name":467,"class":47},"Hospital de Clinicas de Porto Alegre"]