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

Официальное название

Micronutrient Enhancement for Development and Health in Adolescents

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Iron (60 mg)- folic acid (400 ug) [IFA]
  Weekly IFA will be provided in the control arm as standard-of-care for a year
• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Wide Range Achievement Test (WRAT-5) Composite Score [Срок оценки: Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.]
• Height-for-age Z score [Срок оценки: Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• Unmarried 10-18 year old females
• living in their parental home in the study area

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Bangladesh · 1 центр

• JiVitA Project Head Quarters — Rangpur City

Идентификаторы

NCT: NCT07695883 · IRB00035686 · INV-071025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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