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

6. juli 2026 opdateret af: 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 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3000

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Parul Christian, DrPH
  • Telefonnummer: 14109552061
  • E-mail: pchrist1@jhu.edu

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / 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.
Kosttilskud: Iron (60 mg)- folic acid (400 ug) [IFA]
Weekly IFA will be provided in the control arm as standard-of-care for a year
Eksperimentel: 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.
Kosttilskud: 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.
Eksperimentel: 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.
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wide Range Achievement Test (WRAT-5) Composite Score
Tidsramme: WRAT-5 will be administered at 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
WRAT-5 will be administered at baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.
Height-for-age Z score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
WRAT-5 math, reading and spelling scores
Tidsramme: 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)
Tidsramme: 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)
Executive function as assessed by the Digit Span
Tidsramme: Baseline and Endline (12months)
Assessed using Digit Span
Baseline and Endline (12months)
Executive function as assessed by the Number Stroop
Tidsramme: Baseline and Endline (12months)
Assessed using Number Stroop
Baseline and Endline (12months)
Motor function standardized score as assessed by Movement Assessment Batter for Children - 3
Tidsramme: 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
Tidsramme: Baseline and Endline (12 months)
Radiography of radius and tibia
Baseline and Endline (12 months)
Body mass index Z-score
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline (pre-supplementation) and midline (6 months)
Leptin, Estradiol, Osteocalcin
Baseline (pre-supplementation) and midline (6 months)
Health-related Quality of Life (HRQoL)
Tidsramme: At baseline and endline (12 months)
The HRQoL; (EQ-5D-5L) will be used.
At baseline and endline (12 months)
Blood Pressure (mmHg)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline (presupplementation), midline (6months), endline (12 months)
Using kg pressure
Baseline (presupplementation), midline (6months), endline (12 months)
Conners Parent Rating Scale Scores
Tidsramme: Baseline and Endline (12 months)
These standardize scales will be administered to assess behavioral disorders among children.
Baseline and Endline (12 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Parul Christian, DrPH, Johns Hopkins University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00035686
  • INV-071025 (Andet bevillings-/finansieringsnummer: Gates foundation)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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