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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Body Composition; Blood Pressure; HRQOL (Health Related Quality Of Life); Stunting; Bone Mineral Density; Underweight; Linear Growth; Micronutrient Status; Neurodevelopment Outcome; Waist-to-height Ratio
• Intervention / Treatment: Dietary supplement: Iron (60 mg)- folic acid (400 ug) [IFA]; Dietary supplement: Multiple micronutrient supplement [MMS]; Dietary supplement: Multiple micronutrient supplement Plus [MMS+]

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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Parul Christian, DrPH; Phone Number: 14109552061; Email: pchrist1@jhu.edu
• Study Contact Backup: Name: Daniel Erchick, PhD; Email: derchick@jhu.edu

Study Locations

• Bangladesh
  • Rangpur City, Bangladesh
    • JiVitA Project Head Quarters
    • Contact: Towfida Siddiqua, PhD; Phone Number: 880-1718-722147; Email: towfida.jivita@gmail.com
    • Contact: Hasmot Ali, MBBS, MPH; Email: hasmot.jivita@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Iron (60 mg)- folic acid (400 ug) [IFA]; 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.	Dietary supplement: Iron (60 mg)- folic acid (400 ug) [IFA]; Weekly IFA will be provided in the control arm as standard-of-care for a year
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.	Dietary supplement: Multiple micronutrient supplement [MMS]; 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.
Experimental: Multiple micronutrient supplement Plus [MMS+]; 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.	Dietary supplement: Multiple micronutrient supplement Plus [MMS+]; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits
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	Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Baseline (presupplementation) and endline (12 months)
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).	Baseline and endline (12months)
Bone mineral density	Radiography of radius and tibia	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.	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)	Baseline (pre-supplementation) and Midline (6 months)
Endocrine factors	Leptin, Estradiol, Osteocalcin	Baseline (pre-supplementation) and midline (6 months)
Health-related Quality of Life (HRQoL)	The HRQoL; (EQ-5D-5L) will be used.	At baseline and endline (12 months)
Blood Pressure (mmHg)	Blood pressure - systolic and diastolic BP (mm Hg) taken using a BP monitor.	Baseline (pre-supplementation), midline (6 months) and endline (12 months)
% Fat free mass	Body composition will be assessed using anthropometry and skinfold measurements	Baseline (presupplementation), midline (6 months) and endline (12 months)
Waist-to-Height Ratio	Waist circumference and height will be assessed to derive this ratio	Baseline (presupplementation), midline (6months) and endline (12 months)
Hand grip strength	Using kg pressure	Baseline (presupplementation), midline (6months), endline (12 months)
Executive function as assessed by Word Span	Assessed using Word Span	Baseline and Endline (12months)
Executive function as assessed by Dimensional Card Change Sort	Assessed using Dimensional Card Change Sort (DCCS)	Baseline and Endline (12months)
Conners Parent Rating Scale Scores	These standardized scales will be administered to assess behavioral disorders among children.	Baseline and Endline (12 months)

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Bill and Melinda Gates Foundation; International Centre for Diarrhoeal Disease Research, Bangladesh
• Investigators: Principal Investigator: Parul Christian, DrPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Body Weight; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Growth Disorders; Thinness; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Elements; Metals; Pterins; Pteridines; Metals, Heavy; Transition Elements; Folic Acid; Iron
• Other Study ID Numbers: IRB00035686; INV-071025 (Other Grant/Funding Number: Gates foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No