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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to understand iron needs and absorption during pregnancy and lactation in women living in Kenya, where anemia and infections are common. It focuses on pregnant and lactating women, using stable iron isotopes to measure iron absorption, losses, and gains throughout pregnancy and into early infancy. The study enrolls women in their first trimester who previously participated in an iron absorption study. Participants will be followed through pregnancy and the first six months after birth. All women receive standard prenatal care including daily iron and folate supplements as per Kenyan guidelines. A subgroup of women will receive oral and intravenous stable iron isotope tracers in the second and third trimesters to directly assess iron absorption and incorporation into red blood cells. Throughout the study, researchers will collect blood samples from mothers each trimester and at delivery, as well as from infants during the first six months of life. Iron isotope levels, hemoglobin, and other blood markers will be measured to assess iron status and absorption. The study monitors changes in iron isotope abundance at multiple time points during pregnancy and lactation to understand iron requirements and losses in mothers and infants.

Age: 18Years - 45YearsFEMALE
1 location
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Actively Recruiting

Researchers are evaluating how iron is absorbed from three different antenatal supplements a multiple micronutrient supplement MMS with 30 mg iron, MMS with 60 mg iron, and an iron-folic acid IFA supplement with 60 mg iron. This study involves 50 pregnant women in Kenya during their second trimester. The study also aims to understand if daily iron dosing triggers a hormone called hepcidin that could reduce iron absorption, and whether taking supplements every other day might be more effective for treating iron deficiency. Participants will receive the supplements in a randomized crossover design across different blocks. In one block, maize porridge combined with labeled iron compounds and one of the supplements will be given on days 1, 3, and 5. In three additional randomized blocks, water with labeled iron and MMS or IFA supplements will be given on days 1, 2 or 3, and 4, with varying doses of iron 30 mg or 60 mg. The study uses stable iron isotopes to track iron absorption from the supplements. During the study, researchers will measure fractional iron absorption at multiple time points days 19, 36, 53, and 70. Blood tests for hemoglobin, serum ferritin, hepcidin, C-reactive protein, alpha-1-acid glycoprotein, and soluble transferrin receptor will be collected at several intervals to monitor iron status and inflammation. The study is randomized and single-blind, and participants will be monitored closely for safety and adherence throughout the study period lasting about 10 weeks.

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 suggest that the current Ready-to-Use Therapeutic Foods RUTFs may have limited impact on malnutrition or anemia in children, possibly due to high iron content and poor iron absorption in severely acutely malnourished SAM children, which can cause dangerous diarrhea. This study aims to develop an improved RUTF treatment that addresses both acute malnutrition and anemia safely and effectively by assessing iron absorption in children with different nutritional statuses. The study compares healthy children with those suffering from moderate or severe acute malnutrition. Participants will receive RUTF containing a special form of iron 57Fe to measure fractional iron absorption at multiple time points Day 0, 20, 40, and 60. Malnourished children will undergo daily RUTF treatment for 80 days. The study tracks changes in iron absorption and nutritional status throughout this period. Participants will be monitored through measurements of fractional iron absorption, hemoglobin levels, serum ferritin, soluble transferrin receptor, inflammatory markers, body weight, and height at scheduled days from the start until Day 80. These assessments will help researchers understand how malnutrition affects iron absorption and how the RUTF treatment impacts anemia and overall health. The study period extends from December 2025 to June 2026.

Age: 12Months - 54MonthsAll GendersPhase Not Applicable
2 locations