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.
Unmarried 10-18 year old females
living in their parental home in the study area
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
Parallel
Iron (60 mg)- folic acid (400 ug) [IFA]
Dietary supplementWeekly IFA will be provided in the control arm as standard-of-care for a year
Multiple micronutrient supplement [MMS]
Dietary supplementExperimental: 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 supplementExperimental: 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.
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
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.
WRAT-5 math, reading and spelling scores
Individual domain scores derived from the WRAT-5. The mean for each is approximately 70 with SD of 20.
General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II)
This will be assessed using Wechsler Abbreviated Scale of Intelligence (WASI-II). The full scale IQ has a mean (SD) of 75 (12).
Executive function as assessed by Word Span
Assessed using Word Span
Executive function as assessed by Dimensional Card Change Sort
Assessed using Dimensional Card Change Sort (DCCS)
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator
Bill and Melinda Gates Foundation
Collaborator
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