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Not Yet Recruiting NCT07695883

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

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

Sex: Female
Ages: 10 Years – 18 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 3000
Sponsor: Johns Hopkins Bloomberg School of Public Health

Location: JiVitA Project Head Quarters Rangpur City

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07695883). StuddyBuddy aggregates publicly available trial information.