Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

3 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

3000

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Parul Christian, DrPH
  • Numéro de téléphone: 14109552061
  • E-mail: pchrist1@jhu.edu

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Complément alimentaire: Iron (60 mg)- folic acid (400 ug) [IFA]
Weekly IFA will be provided in the control arm as standard-of-care for a year
Expérimental: 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.
Complément alimentaire: 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.
Expérimental: 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.
Complément alimentaire: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Height-for-age Z score
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
WRAT-5 math, reading and spelling scores
Délai: 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)
Délai: 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
Délai: 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
Délai: Baseline and Endline (12 months)
Radiography of radius and tibia
Baseline and Endline (12 months)
Body mass index Z-score
Délai: 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
Délai: 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
Délai: Baseline (pre-supplementation) and midline (6 months)
Leptin, Estradiol, Osteocalcin
Baseline (pre-supplementation) and midline (6 months)
Health-related Quality of Life (HRQoL)
Délai: At baseline and endline (12 months)
The HRQoL; (EQ-5D-5L) will be used.
At baseline and endline (12 months)
Blood Pressure (mmHg)
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline (presupplementation), midline (6months), endline (12 months)
Using kg pressure
Baseline (presupplementation), midline (6months), endline (12 months)
Executive function as assessed by Word Span
Délai: Baseline and Endline (12months)
Assessed using Word Span
Baseline and Endline (12months)
Executive function as assessed by Dimensional Card Change Sort
Délai: Baseline and Endline (12months)
Assessed using Dimensional Card Change Sort (DCCS)
Baseline and Endline (12months)
Conners Parent Rating Scale Scores
Délai: Baseline and Endline (12 months)
These standardized scales will be administered to assess behavioral disorders among children.
Baseline and Endline (12 months)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Johns Hopkins Bloomberg School of Public Health

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Parul Christian, DrPH, Johns Hopkins University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

30 juin 2028

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

6 juillet 2026

Première publication (Réel)

10 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB00035686
  • INV-071025 (Autre subvention/numéro de financement: Gates foundation)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner