[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iron-requirements\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iron-requirements":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100603905","determination-of-iron-absorption-and-losses-in-people-living-at-high-altitude-to-investigate-the-requirements-in-this-population-group-using-a-newly-developed-technique-100603905",false,"NCT07142590","Determination of Iron Absorption and Losses in People Living at High Altitude to Investigate the Requirements in This Population Group Using a Newly Developed Technique","Iron Balance in Humans Living at High Altitude: Defining Requirements and Optimal Biomarker Thresholds Using a Novel Body Iron Labelling Technique Based on Stable Iron Isotopes.","ARIA","Inclusion Criteria:\n\n* Females and males aged 18-45 y\n* BMI: 18 to 25 kg\u002Fm2\n* Body weight \\\u003C70 kg for females, \\\u003C85 kg for males\n* Plasma ferritin \\>25 µg\u002FL\n* Signed informed consent\n\nExclusion Criteria:\n\n* Hb \\\u003C12 g\u002FdL (females), Hb \\\u003C13 g\u002FdL (males), corrected for altitude using the 2024 WHO guidance values for hemoglobin adjustments\n* Inflammation (CRP \\> 5 mg\u002FL)1\n* Plasma ferritin \\>150 µg\u002FL for females and \\>200 µg\u002FL for males\n* Chronic disease known to affect iron metabolism\n* Chronic medications (except for oral contraceptives)\n* Pregnancy (tested at screening) or intention to become pregnant during the course of the study\n* Lactation\n* High physical activity (MET-min\u002Fweek \\> 3000 calculated according to the IPAQ, short version, administered at the screening)\n* Difficulty with blood withdrawal\n* Earlier participation in a study using stable iron isotopes or participation in any clinical study within the last 30 days\n* Smoking\n* Blood donation, blood transfusion or significant blood loss (more than 400 mL) over the past 6 months\n* Intention to regularly donate blood during the 2 years duration of the study\n* No residence in the respective location\u002Faltitude for at least the last 2 years\n* No intention to reside in the respective location\u002Faltitude at least for the next 2 years\n* Participants who are planning to spend an extended period (\\>12 weeks) at a different altitude from their residence location\n* Spending more than 2 nights per week at a different location from residence location\n* Inability to understand the information sheet and the informed consent form due to cognitive or language reasons",true,"ALL","18 Years","45 Years",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26],"NA","Iron is an essential micronutrient responsible for a whealth of biological processes of the human body. Iron plays a fundamental role especially in oxygen transport, by binding to hemoglobin in the blood circulation. Iron intake from the diet needs to be in balance the unavoidable losses that occur daily via different pathways. The recommended daily requirement of iron is based on the balance between absorption and losses and is calculated to maintain a balance so that the absorption equals losses. At higher altitudes, the absorption of iron may be higher due to adaptation mechanisms in response to low oxygen concentration, and to maintain a larger erytroid compartement. However, the long-term effects of altitude on iron balance are unknown. Filling this knowledge gap is important to better understand iron deficiency in populations living at high and moderate altitudes. Therefore, the investigators plan to study people that live at two different altitudes and measure iron absorption and losses over the long term. This will be useful to formulate specific recommendations for this population groups, to expand the knowledge base to better prevent iron deficiency in Switzerland but also worldwide. Participants will be asked to consume a dose of stable iron isotopes. After one year from isotope administration, the isotopes will be equally distributed in all body compartments and any change in the isotope abundance with the normal occurring body iron can be detected. From this point onwards, the investigators can observe the iron turnover and calculate iron absorption and losses per unit of time. At 4 different visits blood samples will be taken from each participant.",[29,30,31],"Iron Absorption","Iron Requirements","Altitude",[33,34,35,36],"iron absorption","altitude","stable iron isotopes","long-term iron balance","RECRUITING","2026-01-13",{"date":40,"type":41},"2026-01-14","ACTUAL",{"date":43,"type":41},"2025-08-22",{"date":45,"type":23},"2028-02",{"name":47,"class":48},"Diego Moretti","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":19,"maxAge":20,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":49},"100514059","iron-absorption-and-requirements-in-pregnancy-and-lactation-100514059","NCT05973552","Iron Absorption and Requirements in Pregnancy and Lactation","Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women","PILLAR_II","Inclusion Criteria:\n\n* Providing consent to the informed consent form\n* Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study\n* Positive pregnancy test and gestational age \\\u003C10 weeks based on history of last menstrual period\n* Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months\n* Assessment of good health by professional staff at Msambweni Hospital\n\nExclusion Criteria:\n\n* Pre-pregnancy body mass index \\>30 kg\u002Fm2\n* Blood transfusion or intravenous iron treatment within 4 months of study start\n* Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)\n* Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)","FEMALE",{"count":60,"type":23},250,"OBSERVATIONAL","Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.\n\nThe primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya.\n\nIn this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.",[30,64,65,66,29],"Pregnancy","Lactation","Infancy","2023-07-31",{"date":69,"type":41},"2023-08-03",{"date":67,"type":23},{"date":72,"type":23},"2026-09-01",{"name":74,"class":48},"University of Oxford"]