Iron absorption from prenatal IFA and MMS supplements in second-trimester Kenyan women
Comparing Iron Absorption From Multiple Micronutrient Supplements and Iron-folate Supplements: a Stable Isotope Study in Kenyan Pregnant Women
This trial tests how well three prenatal iron supplements (30 mg MMS, 60 mg MMS, and 60 mg IFA) are absorbed by Kenyan women in their second trimester, comparing fasted vs fed and daily vs alternate-day dosing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | ETH Zurich Academic / other |
| Locations | 2 sites (Kwale, Kwale County and 1 other locations) |
| Trial ID | NCT07435766 on ClinicalTrials.gov |
What this trial studies
This randomized crossover study will enroll 50 pregnant Kenyan women around the start of the second trimester (approximately 12 weeks) to compare iron bioavailability from three antenatal supplements. Researchers will use stable iron isotopes to directly measure absorption after doses taken in fasted and fed states. The protocol also examines whether daily dosing raises hepcidin and reduces subsequent absorption, and whether alternate-day dosing avoids that effect. Study visits are conducted at two hospitals in Kwale County, Kenya.
Who should consider this trial
Good fit: Healthy pregnant women about 12 (±1) weeks gestation, aged 18–35 years, with hemoglobin ≥80 g/L, body weight under 80 kg, no major chronic diseases, no recent blood loss or transfusion, and not taking other vitamin/mineral supplements are ideal candidates.
Not a fit: Women with severe anemia (Hb <80 g/L), malaria, sickle cell disease or hemoglobin C disease, those outside the age or weight limits, or those already on other supplements are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the results could show which supplement dose and dosing schedule best increases iron absorption and lowers the risk of iron deficiency in pregnancy.
How similar studies have performed: Previous absorption studies using stable iron isotopes and crossover designs have demonstrated that food and dosing schedule influence iron uptake, and some evidence supports alternate-day dosing to improve absorption.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Kwale, Kwale County and 1 other locations
- Kwale Sub County Hospital — Kwale, Kwale County, Kenya (Recruiting)
- Msambweni County Referral Hospital — Msambweni, Kwale County, Kenya (Recruiting)
Study contacts
- Study coordinator: Laura N Wasserfallen, MSc
- Email: laura.wasserfallen@pharma.ethz.ch
- Phone: +41 76 574 88 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.