Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorETH Zurich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
female
pregnant at gestational age 12 (±1) weeks (dated by ultrasound)
age 18 to 35 y
Hb concentration ≥80 g/L
Disqualifiers
severe anemia (defined as Hb <80 g/L)
malaria
sickle cell disease (SS and SC)
hemoglobin C disease (CC).
Trial design
Design model
Crossover
Treatments tested in this trial
MMS with 30 mg iron
Dietary supplementMultiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)
MMS with 60 mg iron
Dietary supplementMultiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)
IFA with 60 mg iron
Dietary supplementIron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Supplement crossover with maize porridge, comparison of iron absorptionExperimental treatment 3 interventions
Group B: Supplement crossover with water, everyday vs. every other dayExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 192
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 363
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 534
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 70Secondary outcomes
1
Hepcidin [µg/dL]
Systemic iron regulator
Time frame
Day 192
Hepcidin [µg/dL]
Systemic iron regulator
Time frame
Day 20/213
Hepcidin [µg/dL]
Systemic iron regulator
Time frame
Day 224
Hepcidin [µg/dL]
Systemic iron regulator
Time frame
Day 36 Source ClinicalTrials.gov