Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study (MEDHA)
2026년 7월 6일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
3000
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Parul Christian, DrPH
- 전화번호: 14109552061
- 이메일: pchrist1@jhu.edu
연구 연락처 백업
- 이름: Daniel Erchick, PhD
- 이메일: derchick@jhu.edu
연구 장소
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Rangpur City, 방글라데시
- JiVitA Project Head Quarters
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연락하다:
- Towfida Siddiqua, PhD
- 전화번호: 880-1718-722147
- 이메일: towfida.jivita@gmail.com
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연락하다:
- Hasmot Ali, MBBS, MPH
- 이메일: hasmot.jivita@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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.
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Weekly IFA will be provided in the control arm as standard-of-care for a year
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실험적: 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.
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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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Wide Range Achievement Test (WRAT-5) Composite Score
기간: WRAT-5 will be administered at baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.
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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
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WRAT-5 will be administered at baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.
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Height-for-age Z score
기간: Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits
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Height will be assessed and expressed as a Z-score using reference standards for children.
Stunting will be defined using HAZ < -2.
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Baseline (pre-supplementation) and at the midline (6 months) and endline (12 months) visits
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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WRAT-5 math, reading and spelling scores
기간: Baseline, midline (6 months) and endline (12 months)
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Individual domain scores derived from the WRAT-5.
The mean for each is approximately 70 with SD of 20.
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Baseline, midline (6 months) and endline (12 months)
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General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II)
기간: Baseline (presupplementation) and endline (12 months)
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This will be assessed using Wechsler Abbreviated Scale of Intelligence (WASI-II).
The full scale IQ has a mean (SD) of 75 (12).
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Baseline (presupplementation) and endline (12 months)
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Executive function as assessed by the Digit Span
기간: Baseline and Endline (12months)
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Assessed using Digit Span
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Baseline and Endline (12months)
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Executive function as assessed by the Number Stroop
기간: Baseline and Endline (12months)
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Assessed using Number Stroop
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Baseline and Endline (12months)
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Motor function standardized score as assessed by Movement Assessment Batter for Children - 3
기간: Baseline and endline (12months)
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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).
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Baseline and endline (12months)
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Bone mineral density
기간: Baseline and Endline (12 months)
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Radiography of radius and tibia
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Baseline and Endline (12 months)
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Body mass index Z-score
기간: At Baseline (pre-supplementation), midline (6 months) and 12 (months)
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BMIZ score will be derived using weight and height measurements using reference standards.
BMIZ < 2 is used to define underweight.
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At Baseline (pre-supplementation), midline (6 months) and 12 (months)
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Nutrient status
기간: Baseline (pre-supplementation) and Midline (6 months)
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Assessed using blood serum/plasma, or urine (vitamin A, D, E, B12, zinc, Hb, iodine, Thyroglobulin)
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Baseline (pre-supplementation) and Midline (6 months)
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Endocrine factors
기간: Baseline (pre-supplementation) and midline (6 months)
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Leptin, Estradiol, Osteocalcin
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Baseline (pre-supplementation) and midline (6 months)
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Health-related Quality of Life (HRQoL)
기간: At baseline and endline (12 months)
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The HRQoL; (EQ-5D-5L) will be used.
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At baseline and endline (12 months)
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Blood Pressure (mmHg)
기간: Baseline (pre-supplementation), midline (6 months) and endline (12 months)
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Blood pressure - systolic and diastolic BP (mm Hg) taken using a BP monitor.
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Baseline (pre-supplementation), midline (6 months) and endline (12 months)
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% Fat free mass
기간: Baseline (presupplementation), midline (6 months) and endline (12 months)
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Body composition will be assessed using anthropometry and skinfold measurements
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Baseline (presupplementation), midline (6 months) and endline (12 months)
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Waist-to-Height Ratio
기간: Baseline (presupplementation), midline (6months) and endline (12 months)
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Waist circumference and height will be assessed to derive this ratio
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Baseline (presupplementation), midline (6months) and endline (12 months)
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Hand grip strength
기간: Baseline (presupplementation), midline (6months), endline (12 months)
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Using kg pressure
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Baseline (presupplementation), midline (6months), endline (12 months)
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Conners Parent Rating Scale Scores
기간: Baseline and Endline (12 months)
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These standardize scales will be administered to assess behavioral disorders among children.
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Baseline and Endline (12 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Parul Christian, DrPH, Johns Hopkins University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2028년 6월 30일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 6일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 6일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00035686
- INV-071025 (기타 보조금/기금 번호: Gates foundation)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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