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

3 september 2026 uppdaterad av: Johns Hopkins Bloomberg School of Public Health

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

3000

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Parul Christian, DrPH
  • Telefonnummer: 14109552061
  • E-post: pchrist1@jhu.edu

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Kosttillskott: Iron (60 mg)- folic acid (400 ug) [IFA]
Weekly IFA will be provided in the control arm as standard-of-care for a year
Experimentell: 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.
Kosttillskott: 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.
Experimentell: 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.
Kosttillskott: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Height-for-age Z score
Tidsram: 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.
Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits
Wide Range Achievement Test (WRAT-5) Composite Score
Tidsram: 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
Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
WRAT-5 math, reading and spelling scores
Tidsram: 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.
Baseline, midline (6 months) and endline (12 months)
General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II)
Tidsram: 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).
Baseline (presupplementation) and endline (12 months)
Motor function standardized score as assessed by Movement Assessment Batter for Children - 3
Tidsram: 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).
Baseline and endline (12months)
Bone mineral density
Tidsram: Baseline and Endline (12 months)
Radiography of radius and tibia
Baseline and Endline (12 months)
Body mass index Z-score
Tidsram: 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.
At Baseline (pre-supplementation), midline (6 months) and 12 (months)
Nutrient status
Tidsram: Baseline (pre-supplementation) and Midline (6 months)
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
Tidsram: Baseline (pre-supplementation) and midline (6 months)
Leptin, Estradiol, Osteocalcin
Baseline (pre-supplementation) and midline (6 months)
Health-related Quality of Life (HRQoL)
Tidsram: At baseline and endline (12 months)
The HRQoL; (EQ-5D-5L) will be used.
At baseline and endline (12 months)
Blood Pressure (mmHg)
Tidsram: Baseline (pre-supplementation), midline (6 months) and endline (12 months)
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
Tidsram: Baseline (presupplementation), midline (6 months) and endline (12 months)
Body composition will be assessed using anthropometry and skinfold measurements
Baseline (presupplementation), midline (6 months) and endline (12 months)
Waist-to-Height Ratio
Tidsram: Baseline (presupplementation), midline (6months) and endline (12 months)
Waist circumference and height will be assessed to derive this ratio
Baseline (presupplementation), midline (6months) and endline (12 months)
Hand grip strength
Tidsram: Baseline (presupplementation), midline (6months), endline (12 months)
Using kg pressure
Baseline (presupplementation), midline (6months), endline (12 months)
Executive function as assessed by Word Span
Tidsram: Baseline and Endline (12months)
Assessed using Word Span
Baseline and Endline (12months)
Executive function as assessed by Dimensional Card Change Sort
Tidsram: Baseline and Endline (12months)
Assessed using Dimensional Card Change Sort (DCCS)
Baseline and Endline (12months)
Conners Parent Rating Scale Scores
Tidsram: Baseline and Endline (12 months)
These standardized scales will be administered to assess behavioral disorders among children.
Baseline and Endline (12 months)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbetspartners

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

Utredare

  • Huvudutredare: Parul Christian, DrPH, Johns Hopkins University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

6 juli 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

10 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00035686
  • INV-071025 (Annat bidrag/finansieringsnummer: Gates foundation)

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