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

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 (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.

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

Interventions

DIETARY_SUPPLEMENT

Iron (60 mg)- folic acid (400 ug) [IFA]

Weekly IFA will be provided in the control arm as standard-of-care for a year

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Parul Christian, DrPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-12-31

Completion

2028-06-30

Countries

• Bangladesh

Study Locations