The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT.

BACKGROUND: Women of reproductive age (WRA) in developing countries are often at risk of micronutrient deficiencies due to inadequate intakes and excessive losses. OBJECTIVE: The purpose of this trial is to assess the effectiveness of United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) versus iron-folic acid (IFA) among WRA in reducing anemia. METHODS: Three parallel groups of WRA will participate in a community-based, individually randomized, double-blinded, placebo-controlled superiority trial. After consent, the sample of 375 mildly or moderately anemic women based on hemoglobin by Hemocue will be randomly assigned across two interventions and one control arm. Trial participants in intervention arms will receive UNIMMAP-MMS or IFA while those in the control arm will receive placebos twice a week for 17 weeks. The primary outcome will be a change in mean hemoglobin (Hb) concentrations. Outcome assessors and study participants will be blinded to the type of supplements and study arm. DISCUSSION: The World Health Organization (WHO) added UNIMMAP-MMS to its essential medicine lists in 2021 but recommended rigorous study. Several factors in addition to inadequate intakes of iron and folic acid contribute to the high prevalence of anemia among WRA in the Somali region. The findings of this study will provide evidence on the effect of UNIMMAP-MMS and IFA on Hb concentrations and anemia prevalence among anemic WRA. TRIAL REGISTRATION: ClinicalTrials.gov NCT05682261. Registered on January 12, 2023.

Simulated effects of home fortification of complementary foods with micronutrient powders on risk of inadequate and excessive intakes in West Gojjam, Ethiopia.

Home fortification of complementary foods (CFs) with multiple micronutrient powders (MNPs) is being scaled up in various countries, but little is known about the prevailing complementary feeding practices and the type and nutrient gaps to be filled with MNPs. The present study evaluated the complementary feeding practices of young children and simulated the risk of inadequate and excessive intakes associated with home fortification with MNPs. We have assessed the sociodemographic status, anthropometry, and complementary feeding practices of young children (N = 122) in Mecha district, rural Ethiopia. Using a 2-day, quantitative 24-hr recall, usual intakes of energy, protein, iron, zinc, and calcium were estimated. The risks of inadequate and excessive iron and zinc intakes with or without home fortification scenarios were assessed. The simulations considered intakes from CFs assuming average breast milk contributions and additional nutrients provided by the MNPs. Stunting was highly prevalent (50%) and was associated with a lower dietary diversity (P = .009) and nutrient intakes from the CFs. Median energy, zinc, and calcium intakes were below the estimated needs from CFs; protein needs were met. Median dietary iron intake appeared adequate, but 76%, 95% CI [68%, 84%], of children had inadequate intake (assuming low bioavailability), whereas another 8%, 95% CI: [3%, 13%], had excessive intakes. Simulation of daily and alternative day's fortification with MNP decreased the prevalence of inadequate iron and zinc intake but significantly increased the risk of excessive intakes that remained unacceptably high for iron (>2.5%). Untargeted MNP interventions may lead to excessive intakes, even in settings where poor complementary feeding practices are prevalent.