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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age10-18
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

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.

Eligibility criteria

Qualifiers

Unmarried 10-18 year old females

living in their parental home in the study area

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

3,000 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborator

Bill and Melinda Gates Foundation

Collaborator