Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy

作者：Emily R. Smith, Alfa Muhihi, Blair J. Wylie, Sabina Mugusi, Said Aboud, Mohamed Bakari, Wafaie W. Fawzi, Shabani Kinyogoli, Erin Oakley, Qing Pan, Mary M. Sando, Victoria Brownlee, Andrea B. Pembe, Christopher R. Sudfeld, Honorati Masanja · 发表于：Trials · 年份：2025 · DOI：10.1186/s13063-025-08906-7 · 被引用次数：3 · 研究领域：Iron Metabolism and Disorders、Hemoglobinopathies and Related Disorders、Pregnancy and preeclampsia studies

BACKGROUND: Antenatal multiple micronutrient supplementation (MMS) has been shown to be more effective than iron-folic acid (IFA) alone in reducing adverse pregnancy and birth outcomes. However, there is a concern that MMS containing 30 mg of iron may be less effective in reducing maternal anemia compared to IFA supplements containing 60 mg of iron. This poses a clinical and programmatic dilemma for countries with a high burden of maternal anemia (> 40% prevalence) where the World Health Organization (WHO) recommends using IFA with 60 mg of iron. METHODS/DESIGN: We will conduct an individually randomized, quadruple-blind superiority trial of daily antenatal MMS in Dar es Salaam, Tanzania (n = 6381 pregnant women). Participants will be randomized to receive a daily MMS regimen during pregnancy containing 60 mg iron, 45 mg iron, or 30 mg iron at a ratio of 1:1:1. The trial participants, outcome assessors (research staff and care providers), investigators, trial statistician, and data analysts will be blinded. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized MMS regimen from enrollment until the time of pregnancy outcome/delivery. The primary outcome is maternal third-trimester moderate or severe anemia (Hb < 10.0 g/dL). The proportion of women who have moderate or severe anemia at 32 weeks of gestation will be compared between MMS containing 60 mg iron versus MMS containing 30 mg iron, as well as MMS containing 45 mg iron...