Micronutrient Enhancement for Development and Health in Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Wide Range Achievement Test (WRAT-5) Composite Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Given the nature of the three types of interventions, and their taste and the regimen, and difficulty in creation of true placebos, this trial will not be masked. Those providing the intervention will be a cadre of community workers separate from the data collection teams.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Unmarried 10-18 year old females
- •living in their parental home in the study area
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Iron (60 mg)- folic acid (400 ug) [IFA] (Dietary Supplement)
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.
干预措施: Multiple micronutrient supplement [MMS] (Dietary Supplement)
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.
干预措施: Multiple micronutrient supplement Plus [MMS+] (Dietary Supplement)
结局指标
主要结局
Wide Range Achievement Test (WRAT-5) Composite Score
时间窗: WRAT-5 will be administered at 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
Height-for-age Z score
时间窗: 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.
Wide Range Achievement Test (WRAT-5) Composite Score
时间窗: 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
次要结局
- WRAT-5 math, reading and spelling scores(Baseline, midline (6 months) and endline (12 months))
- General Intelligence as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI-II)(Baseline (presupplementation) and endline (12 months))
- Executive function as assessed by the Digit Span(Baseline and Endline (12months))
- Executive function as assessed by the Number Stroop(Baseline and Endline (12months))
- Motor function standardized score as assessed by Movement Assessment Batter for Children - 3(Baseline and endline (12months))
- Bone mineral density(Baseline and Endline (12 months))
- Body mass index Z-score(At Baseline (pre-supplementation), midline (6 months) and 12 (months))
- Nutrient status(Baseline (pre-supplementation) and Midline (6 months))
- Endocrine factors(Baseline (pre-supplementation) and midline (6 months))
- Health-related Quality of Life (HRQoL)(At baseline and endline (12 months))
- Blood Pressure (mmHg)(Baseline (pre-supplementation), midline (6 months) and endline (12 months))
- % Fat free mass(Baseline (presupplementation), midline (6 months) and endline (12 months))
- Waist-to-Height Ratio(Baseline (presupplementation), midline (6months) and endline (12 months))
- Hand grip strength(Baseline (presupplementation), midline (6months), endline (12 months))
- Conners Parent Rating Scale Scores(Baseline and Endline (12 months))
- Executive function as assessed by Word Span(Baseline and Endline (12months))
- Executive function as assessed by Dimensional Card Change Sort(Baseline and Endline (12months))