NCT07695883 Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
| NCT ID | NCT07695883 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Neurodevelopment Outcome |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2026-09-27 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,000 participants in total. It began in 2026-09-27 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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
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
Contact & Investigator
Parul Christian, DrPH
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07695883 clinical trial?
This trial is open to female participants only, aged 10 Years or older, up to 18 Years, studying Neurodevelopment Outcome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07695883 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,000 participants.
Is NCT07695883 currently recruiting?
Yes, NCT07695883 is actively recruiting participants. Contact the research team at pchrist1@jhu.edu for enrollment information.
Where is the NCT07695883 trial being conducted?
This trial is being conducted at Rangpur City, Bangladesh.
Who is sponsoring the NCT07695883 clinical trial?
NCT07695883 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Parul Christian, DrPH at Johns Hopkins University. The trial plans to enroll 3,000 participants.