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

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT07695883
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
10 Years - 18 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Iron (60 mg)- folic acid (400 ug) [IFA]
    Weekly IFA will be provided in the control arm as standard-of-care for a year as per government of Bangladesh policy and WHO guidelines for this age group.
  • 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.
  • 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.

Primary Outcome Measure

Wide Range Achievement Test (WRAT-5) Composite Score [ Time Frame: Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits. ]

Central Contacts

Related Studies