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临床试验/NCT04657640
NCT04657640已完成3 期

Scaling-up High-impact Micronutrient Supplementation Interventions to Improve Adolescents' Nutrition and Health in Burkina Faso

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 3,123 人开始时间: 2020年12月11日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
3,123
试验地点
1
主要终点
Anemia Status

研究概览

简要总结

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status, school performance/attendance and development outcomes among adolescents in Burkina Faso.

详细描述

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Burkina Faso. Findings from this study will clarify the optimal supplementation strategy (iron and folic acid alone or adding other essential nutrients) and provide a basis for scale up of national micronutrient supplementation programs to benefit the adolescent population as a whole in Burkina Faso.

This will be a cluster randomized study with 3 arms. 42 schools per country will be enrolled (14 schools per arm) to receive either 1) daily Multiple Micronutrient Supplements (MMS) and weekly Iron and Folic Acid (IFA) for the first 5 weeks and daily MMS for the remainder of the study; or 2) weekly IFA; or 3) to serve as controls. As recommended by the World Health Organization in settings where continuous supplementation is not possible, supplementation will be intermittent. Supplementation will be provided for 3 months, stopped for 3 months over the school summer holidays and resumed for 3 months once students return to school after the holiday. Students in intervention schools will receive supplementation and students in control schools will receive the usual care (which does not include supplementation but does include existing curriculum on nutrition and water, sanitation and hygiene [WASH]). The program will be evaluated comparing effects of weekly IFA and daily MMS on anemia status and school attendance/retention.

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

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 10-17 years
  • Enrolled in secondary school form 1 at study initiation
  • Member of one of the selected classes in a participating school
  • Consent provided by the parent
  • Assent provided by the adolescent
  • Fluency in French

排除标准

  • No informed consent from parent or assent from adolescent
  • Self-reported Pregnancy

结局指标

主要结局

Anemia Status

时间窗: Up to one year

Anemia will be defined as hemoglobin level \<10 g/dL

次要结局

  • School attendance(Up to one year)
  • School retention(Up to one year)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaie Fawzi

Professor of Nutrition, Epidemiology, and Global Health

Harvard School of Public Health (HSPH)

研究点 (1)

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