Neurodevelopment OutcomePhase 3MEDHANCT07695883
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
A Phase 3 study testing Iron (60 mg)- folic acid (400 ug) [IFA], Multiple micronutrient supplement [MMS] and Multiple micronutrient supplement Plus [MMS+] in people with Neurodevelopment Outcome and Linear Growth, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopment Outcome, Linear Growth, Micronutrient Status
- What is being tested?
- Iron (60 mg)- folic acid (400 ug) [IFA], Multiple micronutrient supplement [MMS] and Multiple micronutrient supplement Plus [MMS+]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteBangladesh
- Study dates
- 27 Sep 2026to 30 Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Unmarried 10-18 year old females
- living in their parental home in the study area
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniel Erchick, PhD contact
Bangladesh1 site, 1 recruiting
- Recruiting
JiVitA Project Head Quarters
Rangpur City
Towfida Siddiqua, PhD, 880-1718-722147, towfida.jivita@gmail.com
Hasmot Ali, MBBS, MPH, hasmot.jivita@gmail.com
About this study
Official title: Micronutrient Enhancement for Development and Health in Adolescents
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.
Read the detailed description
Adolescents (10-19 year olds) are an understudied group despite increasing numbers in many regions, especially in low- and middle-income countries (LMICs). Numerous reviews on adolescent health and nutrition have identified major data gaps for this population, including lack of information on the nutritional challenges and the burden of existing deficiencies adolescents face and uncertainty about the level of nutritional support required during this period of rapid physical and cognitive development during and following puberty. The consequences of poor adolescent nutrition for reproductive health and survival as well as bone health in later life among females calls for special attention to vulnerable girls in LMICs.
The primary aim of this study is to determine the efficacy of daily supplementation with MMS (using the UNIMMAP formulation) and an enhanced regimen (MMS+) composed of UNIMMAP plus additional nutrients (calcium, choline, docosahexaenoic acid -DHA, and higher amount of vitamin D) vs. weekly iron-folic acid (IFA) alone on a range of neurodevelopment, biochemical, linear growth and functional outcomes among 10-18 year old girls in rural Bangladesh. The investigators hypothesize that daily MMS or MMS+ will result in an improvement for the co-primary outcomes of school achievement and physical growth (HAZ), and secondary functional outcomes including neurocognitive function, bone health, and biochemical nutrient status among adolescents following 6 and 12 months of supplementation compared with weekly IFA supplementation.
- Conditions
- Neurodevelopment Outcome, Linear Growth, Micronutrient Status, Bone Mineral Density, Underweight, Stunting
- Being tested
- Iron (60 mg)- folic acid (400 ug) [IFA], Multiple micronutrient supplement [MMS], Multiple micronutrient supplement Plus [MMS+]
- Medical subject headings
- Thinness, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron (60 mg)- folic acid (400 ug) [IFA]Dietary supplement
Weekly IFA will be provided in the control arm as standard-of-care for a year
Multiple micronutrient supplement [MMS]Dietary supplement
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.
Multiple micronutrient supplement Plus [MMS+]Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Iron (60 mg)- folic acid (400 ug) [IFA] | Active comparator | Weekly 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. Receives: Dietary Supplement: Iron (60 mg)- folic acid (400 ug) [IFA] |
| Multiple micronutrient supplement [MMS] | Experimental | 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. Receives: Dietary Supplement: Multiple micronutrient supplement [MMS] |
| Multiple micronutrient supplement Plus [MMS+] | Experimental | MMS+ will be a package of nutrient supplements comprising the UNIMMAP tablet and a lipid-based chickpea product with choline, calcium and additional vitamin D taken daily for a year, plus a local DHA/EPA softgel taken three times a week for a year. Receives: Dietary Supplement: Multiple micronutrient supplement Plus [MMS+] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits
Secondary outcomes (15)
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.
Measured: Baseline, midline (6 months) and endline (12 months)
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).
Measured: Baseline (presupplementation) and endline (12 months)
Executive function as assessed by Word Span
Assessed using Word Span
Measured: Baseline and Endline (12months)
Executive function as assessed by Dimensional Card Change Sort
Assessed using Dimensional Card Change Sort (DCCS)
Measured: Baseline and Endline (12months)
Motor function standardized score as assessed by Movement Assessment Batter for Children - 3
Using Movement Assessment Battery for Children -3. Standardized scores for Pegboard, Manual Dexterity, and Balance will be used. Task scores have a mean (SD) of 10(3).
Measured: Baseline and endline (12months)
Bone mineral density
Radiography of radius and tibia
Measured: Baseline and Endline (12 months)
Body mass index Z-score
BMIZ score will be derived using weight and height measurements using reference standards. BMIZ < 2 is used to define underweight.
Measured: At Baseline (pre-supplementation), midline (6 months) and 12 (months)
Nutrient status
Assessed using blood serum/plasma, or urine (vitamin A, D, E, B12, zinc, Hb, iodine, Thyroglobulin)
Measured: Baseline (pre-supplementation) and Midline (6 months)
Endocrine factors
Leptin, Estradiol, Osteocalcin
Measured: Baseline (pre-supplementation) and midline (6 months)
Health-related Quality of Life (HRQoL)
The HRQoL; (EQ-5D-5L) will be used.
Measured: At baseline and endline (12 months)
Blood Pressure (mmHg)
Blood pressure - systolic and diastolic BP (mm Hg) taken using a BP monitor.
Measured: Baseline (pre-supplementation), midline (6 months) and endline (12 months)
% Fat free mass
Body composition will be assessed using anthropometry and skinfold measurements
Measured: Baseline (presupplementation), midline (6 months) and endline (12 months)
Waist-to-Height Ratio
Waist circumference and height will be assessed to derive this ratio
Measured: Baseline (presupplementation), midline (6months) and endline (12 months)
Hand grip strength
Using kg pressure
Measured: Baseline (presupplementation), midline (6months), endline (12 months)
Conners Parent Rating Scale Scores
These standardized scales will be administered to assess behavioral disorders among children.
Measured: Baseline and Endline (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start27 Sep 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopment OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Parul Christian, DrPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695883
- Sponsor's protocol ID
- IRB00035686
- Other IDs
- INV-071025
- Acronym
- MEDHA
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No