RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Johns Hopkins Bloomberg School of Public Health • ClinicalTrials.gov ID: NCT07695883

Registry updated: 2026-10-09

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Description

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.

Interventions

Iron (60 mg)- folic acid (400 ug) [IFA] (Dietary supplement)
Weekly IFA will be provided in the control arm as standard-of-care for a year
Multiple micronutrient supplement [MMS] (Dietary supplement)
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+] (Dietary supplement)
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.

Eligibility criteria

Inclusion Criteria: * Unmarried 10-18 year old females * living in their parental home in the study area Exclusion Criteria: * Married females under 18 years old; * those with a history or diagnosis of chronic or congenital heart disease, chronic kidney or lung disease, cancer, and epilepsy

Conditions

Neurodevelopment Outcome Linear Growth Micronutrient Status Bone Mineral Density Underweight Stunting Body Composition Blood Pressure HRQOL (Health Related Quality Of Life) Waist-to-height Ratio

Locations

JiVitA Project Head Quarters — Rangpur City, Bangladesh

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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