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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Pregnancy and lactation increase iron needs significantly, but current guidelines rely mostly on estimates from non-pregnant populations. This research focuses on iron requirements and absorption in pregnant and lactating women in Kenya, where anemia and infections are common. The study uses stable iron isotopes to provide high-quality data on iron metabolism during pregnancy and lactation. Participants include pregnant women in their first trimester who previously took part in an iron absorption study and received a stable iron isotope. During the study, women will receive standard prenatal care with daily iron and folate supplements following Kenyan guidelines. A subgroup will receive additional oral and intravenous stable iron isotopes in the second and third trimesters to measure iron absorption and incorporation more directly. Throughout pregnancy and up to six months postpartum, blood samples will be collected from mothers and infants to track iron changes using isotope analysis. Various measures including blood volume, hemoglobin mass via the CO-rebreathing method, and iron absorption at multiple gestational ages and postpartum will be assessed. The study aims to precisely quantify iron gains, losses, and absorption during pregnancy, lactation, and early infancy over the 16-month participation period.

Age: 18Years - 45YearsFEMALE
1 location
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Actively Recruiting

Researchers are evaluating iron absorption from three different antenatal supplements in pregnant Kenyan women during their second trimester. The supplements include multiple micronutrient supplementation (MMS) with 30 mg iron, MMS with 60 mg iron, and iron folic acid (IFA) with 60 mg iron. This study uses a randomized crossover design and stable iron isotopes to compare how the body absorbs iron under both fasted and fed conditions. Additionally, it investigates whether daily dosing triggers a hepcidin response that reduces iron absorption and tests if alternate-day dosing might be a better approach to treat iron deficiency. Participants will receive the three types of supplements, each containing specific amounts of iron combined with stable iron isotopes, to track absorption. The MMS supplements contain ferrous fumarate isotopes, while the IFA supplement contains ferrous sulphate isotopes. The study compares the bioavailability of iron from these supplements during different dosing schedules, including daily and alternate-day intake. During the study, researchers will measure fractional iron absorption at multiple time points: days 19, 36, 53, and 70. Pregnant women will be monitored for iron absorption in both fed and fasted states. The study includes assessments of hemoglobin concentration, inflammation status, and adherence to supplement intake. The total participation duration covers these repeated measurements to evaluate iron bioavailability and the effectiveness of different dosing strategies in pregnancy.

Age: 18Years - 35YearsFEMALEPhase Not Applicable
2 locations
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Actively Recruiting

Healthy Volunteer

Reports from the Kenya Red Cross Society in Kwale County have shown that current Ready-to-Use Therapeutic Foods (RUTFs) may have limited effects on malnutrition and anemia in children. The existing RUTFs might contain too much iron, which can cause serious diarrhea in severely acutely malnourished children because their bodies cannot absorb iron properly. This research aims to develop a better RUTF treatment that safely and effectively addresses acute malnutrition and anemia by studying how malnutrition affects iron absorption in children. The study involves measuring iron absorption from RUTFs labeled with 57Fe at several points: Day 0, Day 20, Day 40, and Day 60. Children will receive daily RUTF treatment for 80 days. Iron absorption will be tracked over this period to compare healthy children with those suffering from acute malnutrition and to observe changes in malnourished children during treatment. Participants will be closely monitored throughout the study with assessments of fractional iron absorption at the specified days. The main outcomes measured are fractional iron absorption at Days 0, 20, 40, and 60. This study focuses on children aged 1 to 4.5 years, with careful evaluation of their nutritional status and iron uptake. The information gathered aims to improve treatment approaches for malnourished children in Kenya.

Age: 12Months - 54MonthsAll GendersPhase Not Applicable
2 locations
Msambweni Clinical Trials | DecenTrialz