Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
MEDHA
2 other identifiers
interventional
3,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 10, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2028
July 15, 2026
July 1, 2026
1.3 years
July 6, 2026
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Wide Range Achievement Test (WRAT-5) Composite Score
The Wide Range Achievement Test assess reading, writing and arithmetic and is a school achievement test. The total score on this test will be used. The mean for the total composite score is 100 and SD is 15. Most scores fall between 70 and 130, with higher scores indicating above-average achievement and lower scores indicating below-average achievement
Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.
Height-for-age Z score
Height will be assessed and expressed as a Z-score using reference standards for children. Stunting will be defined using HAZ \< -2.
Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits
Secondary Outcomes (15)
WRAT-5 math, reading and spelling scores
Baseline, midline (6 months) and endline (12 months)
General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II)
Baseline (presupplementation) and endline (12 months)
Executive function as assessed by the Digit Span
Baseline and Endline (12months)
Executive function as assessed by the Number Stroop
Baseline and Endline (12months)
Motor function standardized score as assessed by Movement Assessment Batter for Children - 3
Baseline and endline (12months)
- +10 more secondary outcomes
Study Arms (3)
Iron (60 mg)- folic acid (400 ug) [IFA]
ACTIVE COMPARATORWeekly 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.
Multiple micronutrient supplement [MMS]
EXPERIMENTALA 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+]
EXPERIMENTALMMS+ 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.
Interventions
Weekly IFA will be provided in the control arm as standard-of-care for a year
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.
Eligibility Criteria
You may qualify if:
- Unmarried 10-18 year old females
- living in their parental home in the study area
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
JiVitA Project Head Quarters
Rangpur City, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Parul Christian, DrPH
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Given the nature of the three types of interventions, and their taste and the regimen, and difficulty in creation of true placebos, this trial will not be masked. Those providing the intervention will be a separate cadre of community workers than the data collection teams.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 10, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
July 15, 2026
Record last verified: 2026-07