Effect Of Multiple Micronutrient Supplementation and Iron-Folic Acid Supplementation on Hemoglobin Levels of Pregnant Women, Fetal Growth and Birth Outcome in Ogbomoso: Protocol of A Randomized Control Trial

Background Maternal nutrition during pregnancy is critical for both maternal and fetal health, with inadequate intake of essential nutrients linked to adverse outcomes such as maternal anemia, intrauterine growth restriction, and low birth weight. Maternal malnutrition is a major public health issue in low- and middle-income countries, contributing to high maternal and infant mortality rates. While iron and folic acid (IFA) supplementation is a standard intervention to prevent anemia and neural tube defects, micronutrient deficiencies often extend beyond iron and folic acid, necessitating a broader approach. Multiple micronutrient supplementation (MMS), which includes vitamins and minerals like vitamin A, D, zinc, and selenium, has shown promise in improving maternal and neonatal outcomes. Objective The objective of this study is to assess the effect of Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA) supplementation on maternal hemoglobin levels during pregnancy, fetal growth, and birth outcomes in Ogbomosho, Oyo State, Nigeria. Methods:- This is a 2-study arm double-blind, multi-stage Randomized Control Trial. It is a double centered study involving pregnant women with recruitment of participants into the study commencing at 24 gestation weeks with 2 study arms, a group would be on IFA while another group would be on MMS. Maternal Hemoglobin, Fetal growth (fetal weight, fetal length, fetal adnominal circumference) would be measured and monitored at baseline (24 weeks of gestation), 4 weeks follow up and at delivery. The study plan to recruit a maximum of 120 participants from both study centers. Discussion The study would determine the effect of MMS and IFA supplementation on maternal hemoglobin levels, fetal growth and birth outcome. The findings of this study will contribute to the growing body of evidence on the role of multiple micronutrient supplementation (MMS) in improving maternal and fetal health outcomes. Trial Registration The study has also been registered with the Pan African Clinical Trial Registry with approval number ( https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=31868). PACTR202409756247389, registered on 19th September 2024.