A Phase 3 interventional study of Iron (60 mg)- folic acid (400 ug) [IFA] and Multiple micronutrient supplement [MMS] in Neurodevelopment Outcome, Linear Growth and Micronutrient Status, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 1 site in Bangladesh. Open to female participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Prevention
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.
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.
66 studies on the registry are indexed under Thinness; 11 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 287 across 43 interventional studies indexed under Thinness.
Browse Thinness studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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]
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]
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+]
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.
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.
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
Time frame: 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.
Time frame: Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits
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.
Time frame: 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).
Time frame: Baseline (presupplementation) and endline (12 months)
Executive function as assessed by Word Span
Assessed using Word Span
Time frame: Baseline and Endline (12months)
Executive function as assessed by Dimensional Card Change Sort
Assessed using Dimensional Card Change Sort (DCCS)
Time frame: 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).
Time frame: Baseline and endline (12months)
Bone mineral density
Radiography of radius and tibia
Time frame: 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.
Time frame: 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)
Time frame: Baseline (pre-supplementation) and Midline (6 months)
Endocrine factors
Leptin, Estradiol, Osteocalcin
Time frame: Baseline (pre-supplementation) and midline (6 months)
Health-related Quality of Life (HRQoL)
The HRQoL; (EQ-5D-5L) will be used.
Time frame: At baseline and endline (12 months)
Blood Pressure (mmHg)
Blood pressure - systolic and diastolic BP (mm Hg) taken using a BP monitor.
Time frame: Baseline (pre-supplementation), midline (6 months) and endline (12 months)
% Fat free mass
Body composition will be assessed using anthropometry and skinfold measurements
Time frame: Baseline (presupplementation), midline (6 months) and endline (12 months)
Waist-to-Height Ratio
Waist circumference and height will be assessed to derive this ratio
Time frame: Baseline (presupplementation), midline (6months) and endline (12 months)
Hand grip strength
Using kg pressure
Time frame: Baseline (presupplementation), midline (6months), endline (12 months)
Conners Parent Rating Scale Scores
These standardized scales will be administered to assess behavioral disorders among children.
Time frame: Baseline and Endline (12 months)
Started Sep 2026 (actual). Primary completion is estimated for Mar 2028, 18 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: start Oct 2026 → Sep 2026 and primary completion Dec 2027 → Mar 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins Bloomberg School of Public Health →