Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07695883

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Neurodevelopment Outcome Blood Pressure Body Composition Body Weight Bone Mineral Density Growth Disorders HRQOL (Health Related Quality Of Life) Linear Growth Micronutrient Status Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stunting Thinness Underweight Waist-to-height Ratio

Age range

10 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Wide Range Achievement Test (WRAT-5) Composite Score

    Time frame: Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.

    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

  2. Height-for-age Z score

    Time frame: Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits

    Height will be assessed and expressed as a Z-score using reference standards for children. Stunting will be defined using HAZ < -2.

Secondary outcomes

  1. WRAT-5 math, reading and spelling scores

    Time frame: Baseline, midline (6 months) and endline (12 months)

    Individual domain scores derived from the WRAT-5. The mean for each is approximately 70 with SD of 20.

  2. General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II)

    Time frame: Baseline (presupplementation) and endline (12 months)

    This will be assessed using Wechsler Abbreviated Scale of Intelligence (WASI-II). The full scale IQ has a mean (SD) of 75 (12).

  3. Executive function as assessed by the Digit Span

    Time frame: Baseline and Endline (12months)

    Assessed using Digit Span

  4. Executive function as assessed by the Number Stroop

    Time frame: Baseline and Endline (12months)

    Assessed using Number Stroop

  5. Motor function standardized score as assessed by Movement Assessment Batter for Children - 3

    Time frame: Baseline and endline (12months)

    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).

  6. Bone mineral density

    Time frame: Baseline and Endline (12 months)

    Radiography of radius and tibia

  7. Body mass index Z-score

    Time frame: At Baseline (pre-supplementation), midline (6 months) and 12 (months)

    BMIZ score will be derived using weight and height measurements using reference standards. BMIZ < 2 is used to define underweight.

  8. Nutrient status

    Time frame: Baseline (pre-supplementation) and Midline (6 months)

    Assessed using blood serum/plasma, or urine (vitamin A, D, E, B12, zinc, Hb, iodine, Thyroglobulin)

  9. Endocrine factors

    Time frame: Baseline (pre-supplementation) and midline (6 months)

    Leptin, Estradiol, Osteocalcin

  10. Health-related Quality of Life (HRQoL)

    Time frame: At baseline and endline (12 months)

    The HRQoL; (EQ-5D-5L) will be used.

  11. Blood Pressure (mmHg)

    Time frame: Baseline (pre-supplementation), midline (6 months) and endline (12 months)

    Blood pressure - systolic and diastolic BP (mm Hg) taken using a BP monitor.

  12. % Fat free mass

    Time frame: Baseline (presupplementation), midline (6 months) and endline (12 months)

    Body composition will be assessed using anthropometry and skinfold measurements

  13. Waist-to-Height Ratio

    Time frame: Baseline (presupplementation), midline (6months) and endline (12 months)

    Waist circumference and height will be assessed to derive this ratio

  14. Hand grip strength

    Time frame: Baseline (presupplementation), midline (6months), endline (12 months)

    Using kg pressure

  15. Conners Parent Rating Scale Scores

    Time frame: Baseline and Endline (12 months)

    These standardize scales will be administered to assess behavioral disorders among children.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Erchick, PhD

CONTACT

[email protected]

Parul Christian, DrPH

CONTACT

[email protected]

14109552061

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study title

Micronutrient Enhancement for Development and Health in Adolescents

Acronym: MEDHA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.