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

RecruitingPhase 3Ages 10 Years - 18 YearsFemaleJohns Hopkins Bloomberg School of Public Health
NCT07695883 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
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
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What it tests

  • Iron (60 mg)- folic acid (400 ug) [IFA]
  • Multiple micronutrient supplement [MMS]
  • Multiple micronutrient supplement Plus [MMS+]
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Where

1 site
JiVitA Project Head Quarters
Rangpur City, Bangladesh
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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