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

Study acronym: MEDHA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 31, 2027 → Mar 31, 2028
See other at-risk trials from Johns Hopkins Bloomberg School of Public Health

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Primary completion pushed from Dec 31, 2027 to Mar 31, 2028
    • Start date changed from estimate of Oct 1, 2026 to Sep 27, 2026
    • Secondary endpoints: details revised at 5 of 15 entries
    • Site details revised
    • Eligibility criteria expanded, about 4 words
  2. Start date: Sep 1, 2026 to Oct 1, 2026v4
  3. Secondary endpoints revised (15)v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07695883
Lead Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation
Conditions
(from sponsor)		 Neurodevelopment Outcome, Linear Growth, Micronutrient Status, Bone Mineral Density, Underweight, Stunting, Body Composition, Blood Pressure +2 more
Related terms Growth Disorders, Thinness
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov