Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MMS with 30 mg iron, MMS with 60 mg iron, IFA with 60 mg iron.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Iron Absorption From Multiple Micronutrient Supplements and Iron-folate Supplements: a Stable Isotope Study in Kenyan Pregnant Women
Overview
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.
Interventions
- Dietary supplement MMS with 30 mg iron
Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe) - Dietary supplement MMS with 60 mg iron
Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe) - Dietary supplement IFA with 60 mg iron
Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)
Primary outcome measures
- Fractional iron absorption (%) [Time frame: Day 19]
- Fractional iron absorption (%) [Time frame: Day 36]
- Fractional iron absorption (%) [Time frame: Day 53]
- Fractional iron absorption (%) [Time frame: Day 70]
Secondary outcome measures (12)
- Hepcidin [µg/dL] [Time frame: Day 19]
- Hepcidin [µg/dL] [Time frame: Day 20/21]
- Hepcidin [µg/dL] [Time frame: Day 22]
- Hepcidin [µg/dL] [Time frame: Day 36]
- Hepcidin [µg/dL] [Time frame: Day 37/38]
- Hepcidin [µg/dL] [Time frame: Day 39]
- Hepcidin [µg/dL] [Time frame: Day 53]
- Hepcidin [µg/dL] [Time frame: Day 54/55]
- Hepcidin [µg/dL] [Time frame: Day 56]
- Hemoglobin (g/dL) [Time frame: Day 1]
- Hemoglobin (g/dL) [Time frame: Day 19]
- Hemoglobin (g/dL) [Time frame: Day 36]
Eligibility criteria
Inclusion criteria
- female
- pregnant at gestational age 12 (±1) weeks (dated by ultrasound)
- age 18 to 35 y
- Hb concentration ≥80 g/L
- absence of significant inflammation
- body weight <80 kg
- no major chronic diseases
- no intake of vitamin and mineral supplements outside of this study in the 1-2 weeks between screening and study start and during the study
- no blood transfusion, blood donation, or significant blood loss over the past 4 months
Exclusion criteria
- severe anemia (defined as Hb <80 g/L)
- malaria
- sickle cell disease (SS and SC)
- hemoglobin C disease (CC).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Kenya · 2 centers
- Kwale Sub County Hospital — Kwale
- Msambweni County Referral Hospital — Msambweni
Identifiers
NCT: NCT07435766 · PROUD