Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia
George Washington University
6,381 participants
Mar 3, 2025
INTERVENTIONAL
Conditions
Summary
This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.
Eligibility
Inclusion Criteria5
- Attending first ANC visit at study clinics
- Pregnant women < 20 weeks gestation by last menstrual period (LMP)
- Aged ≥ 18 years old
- Intending to stay in Dar es Salaam until 6 weeks post delivery
- Provides informed consent
Exclusion Criteria4
- Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
- Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
- Concurrently enrolled in another nutritional clinical trial
- Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.
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Interventions
MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization until delivery.
MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.
MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06079918