Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study

Overview

MEDHA is a randomized controlled trial among 10-18 year old girls to examine the use-case of the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS) formulation and to test an enhanced regimen (MMS+) with additional nutrients, vs. weekly iron-folic acid as standard of care on outcomes of neurodevelopment, linear growth, biochemical status, bone health, and other functional and health outcomes. This study is an individually randomized, open-label, three-arm trial of 3,000 participants supplemented for 12 months to assess the efficacy and safety of nutrient supplementation. Results of the study will inform the design of nutritional interventions and policy for this age group. In the context of the trial, the investigators will also do in-depth clinical and health assessments and collect biospecimens for a bio-archive for future deep-phenotyping of this population. This study will be conducted at the Johns Hopkins Bangladesh JiVitA field site in rural Gaibandha District of Bangladesh.

Adolescents (10-19 year olds) are an understudied group despite increasing numbers in many regions, especially in low- and middle-income countries (LMICs). Numerous reviews on adolescent health and nutrition have identified major data gaps for this population, including lack of information on the nutritional challenges and the burden of existing deficiencies adolescents face and uncertainty about the level of nutritional support required during this period of rapid physical and cognitive development during and following puberty. The consequences of poor adolescent nutrition for reproductive health and survival as well as bone health in later life among females calls for special attention to vulnerable girls in LMICs. The primary aim of this study is to determine the efficacy of daily supplementation with MMS (using the UNIMMAP formulation) and an enhanced regimen (MMS+) composed of UNIMMAP plus additional nutrients (calcium, choline, docosahexaenoic acid -DHA, and higher amount of vitamin D) vs. weekly iron-folic acid (IFA) alone on a range of neurodevelopment, biochemical, linear growth and functional outcomes among 10-18 year old girls in rural Bangladesh. The investigators hypothesize that daily MMS or MMS+ will result in an improvement for the co-primary outcomes of school achievement and physical growth (HAZ), and secondary functional outcomes including neurocognitive function, bone health, and biochemical nutrient status among adolescents following 6 and 12 months of supplementation compared with weekly IFA supplementation.