Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania ( MMS-MAP ) - MMS vs IFA Trial

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania ( MMS-MAP ) - MMS vs IFA Trial

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- MMS Versus IFA Crossover Trial

Ifakara Health Institute, Harvard School of Public Health (HSPH), Muhimbili University of Health and Allied Sciences, Africa Academy for Public Health, Columbia University

This is a mixed methods cross-over study to compare acceptability of IFA with 60 mg of iron to MMS with 60 mg of iron. This cross-over study will help contribute evidence to the remaining question about acceptability, preference adherence, and side effects between IFA and MMS (with the same amount of iron). By holding the amount of iron constant, the study can help answer the question about whether the addition of micronutrients affects adherence or acceptability.

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.

Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months

Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months

IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization

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.

Inclusion Criteria: Attending first ANC visit at the study clinic Pregnant women ≤ 15 weeks of gestation Aged ≥ 18 years Intending to stay in the study area for the duration of study Provides informed consent Exclusion Criteria: Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care) Sickle cell disease (homozygous) as tested by HemoTypeSC Concurrent participation in other nutritional supplementation trial