Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study (MEDHA)
2026年9月3日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
3000
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Parul Christian, DrPH
- 电话号码：14109552061
- 邮箱：pchrist1@jhu.edu
研究联系人备份
- 姓名：Daniel Erchick, PhD
- 邮箱：derchick@jhu.edu
学习地点
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Rangpur City、孟加拉国
- JiVitA Project Head Quarters
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接触：
- Towfida Siddiqua, PhD
- 电话号码：880-1718-722147
- 邮箱：towfida.jivita@gmail.com
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接触：
- Hasmot Ali, MBBS, MPH
- 邮箱：hasmot.jivita@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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实验性的：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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实验性的：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.
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Height-for-age Z score
大体时间：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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Wide Range Achievement Test (WRAT-5) Composite Score
大体时间：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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Baseline (pre-supplementation) and at midline (6 months) and endline (12 month) visits.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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WRAT-5 math, reading and spelling scores
大体时间：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)
大体时间：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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Motor function standardized score as assessed by Movement Assessment Batter for Children - 3
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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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Executive function as assessed by Word Span
大体时间：Baseline and Endline (12months)
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Assessed using Word Span
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Baseline and Endline (12months)
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Executive function as assessed by Dimensional Card Change Sort
大体时间：Baseline and Endline (12months)
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Assessed using Dimensional Card Change Sort (DCCS)
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Baseline and Endline (12months)
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Conners Parent Rating Scale Scores
大体时间：Baseline and Endline (12 months)
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These standardized scales will be administered to assess behavioral disorders among children.
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Baseline and Endline (12 months)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Parul Christian, DrPH、Johns Hopkins University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年6月30日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月6日
首次发布 (实际的)
2026年7月10日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
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