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Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
Sponsor: Johns Hopkins Bloomberg School of Public Health
Summary
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 Multiple Micronutrient Supplements (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, placebo-controlled, 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.
Official title: Micronutrient Enhancement for Development and Health in Adolescents
Key Details
Gender
FEMALE
Age Range
10 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
3000
Start Date
2026-09-01
Completion Date
2028-06-30
Last Updated
2026-07-15
Healthy Volunteers
Yes
Conditions
Interventions
Iron (60 mg)- folic acid (400 ug) [IFA]
Weekly IFA will be provided in the control arm as standard-of-care for a year
Multiple micronutrient supplement [MMS]
Experimental: Multiple micronutrient supplement \[MMS\] A daily MMS supplement containing 15 micronutrients using the UNIMMAP (United Nations International Multiple Micronutrient Antenatal Preparation) formulation. This will be provided in a daily tablet form for a year.
Multiple micronutrient supplement Plus [MMS+]
Experimental: Multiple micronutrient supplement Plus \[MMS+\] MMS+ will be a package of nutrient supplements comprising the UNIMMAP tablet, plus a lipid-based chickpea product with choline, calcium and additional vitamin D, plus a local DHA/EPA softgel taken daily for a year.
Locations (1)
JiVitA Project Head Quarters
Rangpur City, Bangladesh