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

Phase III Interventional Neurodevelopment Outcome Linear Growth Micronutrient Status Bone Mineral Density

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iron (60 mg)- folic acid (400 ug) [IFA], Multiple micronutrient supplement [MMS], Multiple micronutrient supplement Plus [MMS+].
Who it may be relevant to
Registry conditions: Neurodevelopment Outcome, Linear Growth, Micronutrient Status, Bone Mineral Density. Basic parameters: 10 years — 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bangladesh
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Micronutrient Enhancement for Development and Health in Adolescents

Overview

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.

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.

Interventions

  • 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
  • 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.
  • 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.

Primary outcome measures

  • Wide Range Achievement Test (WRAT-5) Composite Score [Time frame: Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.]
  • Height-for-age Z score [Time frame: Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits]
Secondary outcome measures (12)
  • WRAT-5 math, reading and spelling scores [Time frame: Baseline, midline (6 months) and endline (12 months)]
  • General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II) [Time frame: Baseline (presupplementation) and endline (12 months)]
  • Executive function as assessed by Word Span [Time frame: Baseline and Endline (12months)]
  • Executive function as assessed by Dimensional Card Change Sort [Time frame: Baseline and Endline (12months)]
  • Motor function standardized score as assessed by Movement Assessment Batter for Children - 3 [Time frame: Baseline and endline (12months)]
  • Bone mineral density [Time frame: Baseline and Endline (12 months)]
  • Body mass index Z-score [Time frame: At Baseline (pre-supplementation), midline (6 months) and 12 (months)]
  • Nutrient status [Time frame: Baseline (pre-supplementation) and Midline (6 months)]
  • Endocrine factors [Time frame: Baseline (pre-supplementation) and midline (6 months)]
  • Health-related Quality of Life (HRQoL) [Time frame: At baseline and endline (12 months)]
  • Blood Pressure (mmHg) [Time frame: Baseline (pre-supplementation), midline (6 months) and endline (12 months)]
  • % Fat free mass [Time frame: Baseline (presupplementation), midline (6 months) and endline (12 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Bangladesh · 1 center
  • JiVitA Project Head Quarters — Rangpur City

Identifiers

NCT: NCT07695883 · IRB00035686 · INV-071025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗