Project Title: Individually randomized trial of higher-dose iron (60mg,45mg) compared to low-dose iron (30gm) in multiple micronutrients supplements in Pregnancy on moderate and severe material anemia.
Project Description: This randomized controlled trial will assess the effect of MMS containing 60 and 45 mg iron as compared to MMS that contains 30 mg of iron (standard MMS dose) on maternal anemia and other important maternal and infant health outcomes. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the optimal dose of iron to use in MMS. It aims to produce causal evidence on whether... This randomized controlled trial will assess the effect of MMS containing 60 and 45 mg iron as compared to MMS that contains 30 mg of iron (standard MMS dose) on maternal anemia and other important maternal and infant health outcomes. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the optimal dose of iron to use in MMS. It aims to produce causal evidence on whether maternal multiple micronutrient supplements (MMS) containing 60 or 45 mg of iron is superior to MMS containing 30 mg of iron (standard' UNIMMAP formulation) in the context of Tanzania where maternal anemia is a severe public health problem. Primary Aims 1. Assess the superiority of MMS containing 60 mg or 45 mg iron as compared to MMS containing 30 mg iron (standard MMS formulation) on maternal third-trimester hemoglobin concentrations. 2. Determine the relative effect of the iron dosage of MMS on important secondary maternal, fetal, and infant outcomes including maternal third trimester and 6 weeks postpartum iron deficiency, anemia, and iron deficiency anemia; fetal death; and infant birth weight and iron status at 6 weeks of age. 3, Evaluate the relative effect of the iron dose in MMS on side effects (nausea, constipation, heartburn, diarrhea, etc.) and adherence to supplementation. 4. To qualitatively assess acceptability, adherence and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron and between MMS formulation with 60 mg of iron and IFA containing 60 mg of iron through cross-over design Study design The study will have three components namely, (i) an individual randomized clinical trial, (ii) MMS iron dose cross over trial and (iii) MMS-IFA cross over trial. Study Sites: The study will take place at selected public antenatal care clinics in Dar es Salaam, Tanzania [(Mnazi Moja Hospital (AKC), Mbagala Rangi Tatu Hospital (MRT), Buguruni Health Center (BUG), Sinza Hospital (SIN), Kimara Health Center (KIM), Mbezi Health Center (MBZ), Tegeta Health Center (TEG), and Vijibweni Hospital (VIJ)]. Study procedures: Pregnant women (age 18 years or older) who attend an antenatal care clinic for the first time during their first or second trimester will be invited, be pre-screened, screened for eligibility and consented for enrollment to the study upon meeting the inclusion criteria. The total sample size required is 6,381 pregnant women for the clinical trial component, 156 pregnant women for the MMS Iron Dose Cross Over trial component and 130 pregnant women for the MMS — IFA Cross Over trial component. Participants will be followed at their routine ANC visits until study discharge. Transport allowances will be provided for study visits that do not occur at the same time as regular ANC visits. As a result, enrolled women in Tanzania will receive a 2,000 Tanzanian Shilling ($0.89) transport allowance for visits that are in addition to routine ANC. Outcomes: The primary outcome will be moderate or severe anemia during third trimester of pregnancy. Secondary outcomes will include standard MCH indicators (Mortality, Preterm birth, SGA, etc), Preeclampsia, Perinatal hemorrhage, Maternal peripartum infections) Study MQnitorinq: The Data Safety Monitoring Board (DSMB) will be the technical body responsible for monitoring and assessing the safety of the trial. The DSMB will be composed of five members — including at least one epidemiologist, a statistician, and a clinician/social scientist. We will hire an independent, local clinical trial monitor who will assess the project eve 6 months as required in Tanzania, The study investigators from all collaborating institutions will conduct aminimum of two internal monitoring visit to each site during the first year of implementation, once during the second year, and once to close the dab (4 total monitoring visits). Data access and dissemination of findings: Only the local Tanzanian research investigators, Harvard University and George Washington University Investigators, study coordinator, data manager, and data team will have access to the server data in Dar es Salaam. Only Harvard Investigators and seff will have access to the Channing Lab server in Boston During the study (after un-blinding process) and upon completion of the trial, we will publish key research findings in peer-reviewed journals with suitable audiences. Since the study has potential benefits to the population level, we will also relate the findings back to the study participants and local communities to both acknowledge their contribution and to share knowledge for capacity building purposes
Principal Investigator : Floriana Kimaro
Department Name :
Time frame: (2022-10-31) - (2025-09-30)
Bill and Melinda Gates Foundation (BMGF) (Prime)
External Collaborating Partners
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