An interventional study of MMS with 30 mg iron and MMS with 60 mg iron in Pregnancy, sponsored by ETH Zurich. Recruiting at 2 sites in Kenya. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by ETH Zurich · Not applicable, Interventional, and Other
This study evaluates iron absorption from three antenatal supplements, 30 mg MMS, 60 mg MMS, and 60 mg IFA, in 50 pregnant Kenyan women in their second trimester. Using a randomized crossover design and stable iron isotopes, we will compare bioavailability in both fasted and fed states. Additionally, the trial will investigate if daily dosing triggers a hepcidin response that inhibits subsequent absorption, testing whether alternate-day dosing is a more effective strategy for treating iron deficiency.
Exclusion Criteria:
1 Block: Maize porridge with labelled ferrous fumarate or ferrous sulphate (54Fe, 57Fe or 58Fe) combined with either MMS with 30 mg of iron, MMS with 60 mg of iron, IFA with 60 mg of iron, given at day 1, day 3 and day 5
Dietary Supplement: MMS with 30 mg iron · Dietary Supplement: MMS with 60 mg iron · Dietary Supplement: IFA with 60 mg iron
Three blocks in randomized order: Block 1: Water with labelled ferrous fumarate (54Fe, 57Fe or 58Fe, randomized) combined with MMS with 30 mg of iron given at day 1, day 2/3 (randomized), day 4 Block 2: Water with labelled ferrous fumarate (54Fe, 57Fe or 58Fe, randomized) combined with MMS with 60 mg of iron given at day 1, day 2/3 (randomized), day 4 Block 3: Water with labelled ferrous sulphate (54Fe, 57Fe or 58Fe, randomized) combined with IFA with 60 mg of iron given at day 1, day 2/3 (randomized), day 4
Dietary Supplement: MMS with 30 mg iron · Dietary Supplement: MMS with 60 mg iron · Dietary Supplement: IFA with 60 mg iron
Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)
Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)
Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)
Fractional iron absorption (%)
Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.
Time frame: Day 19
Fractional iron absorption (%)
Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.
Time frame: Day 36
Fractional iron absorption (%)
Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.
Time frame: Day 53
Fractional iron absorption (%)
Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.
Time frame: Day 70
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 19
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 20/21
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 22
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 36
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 37/38
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 39
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 53
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 54/55
Hepcidin [µg/dL]
Systemic iron regulator
Time frame: Day 56
Hemoglobin (g/dL)
Iron status marker
Time frame: Day 1
Hemoglobin (g/dL)
Iron status marker
Time frame: Day 19
Hemoglobin (g/dL)
Iron status marker
Time frame: Day 36
Hemoglobin (g/dL)
Iron status marker
Time frame: Day 53
Hemoglobin (g/dL)
Iron status marker
Time frame: Day 70
Serum Ferritin (µg/L)
Iron status marker
Time frame: Day 1
Serum Ferritin (µg/L)
Iron status marker
Time frame: Day 19
Serum Ferritin (µg/L)
Iron status marker
Time frame: Day 36
Serum Ferritin (µg/L)
Iron status marker
Time frame: Day 53
C-reactive protein (mg/L)
Chronic inflammation marker
Time frame: Day 1
C-reactive protein (mg/L)
Chronic inflammation marker
Time frame: Day 19
C-reactive protein (mg/L)
Chronic inflammation marker
Time frame: Day 36
C-reactive protein (mg/L)
Chronic inflammation marker
Time frame: Day 53
Alpha-1-acid Glycoprotein (g/L)
Acute inflammation marker
Time frame: Day 1
Alpha-1-acid Glycoprotein (g/L)
Acute inflammation marker
Time frame: Day 19
Alpha-1-acid Glycoprotein (g/L)
Acute inflammation marker
Time frame: Day 36
Alpha-1-acid Glycoprotein (g/L)
Acute inflammation marker
Time frame: Day 53
soluble Transferrin Receptor (mg/L)
Iron status marker
Time frame: Day 1
soluble Transferrin Receptor (mg/L)
Iron status marker
Time frame: Day 19
soluble Transferrin Receptor (mg/L)
Iron status marker
Time frame: Day 36
soluble Transferrin Receptor (mg/L)
Iron status marker
Time frame: Day 53
Plan to share: No
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