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临床试验/NCT05104554
NCT05104554已完成不适用

School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 2,480 人开始时间: 2022年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,480
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 and school performance/attendance among in-school adolescents in Zanzibar, Tanzania.

详细描述

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Zanzibar. 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 Zanzibar.

This will be a cluster randomized study with 3 arms. At the beginning of the academic year, 42 schools will be enrolled (14 schools per arm) to receive either 1) supplementation with weekly iron and folic acid (IFA); 2) supplementation with daily multiple micronutrient supplements (MMS) (including iron and folic acid as components); or 3) to serve as controls. 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 at the end of year 1, comparing effects of weekly IFA and daily MMS on anemia status and school attendance/performance. The more effective strategy (MMS or IFA) will be scaled up to all the study schools for year 2 of the intervention, and the outcomes will be re-assessed.

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 Swahili and/or English

排除标准

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

研究组 & 干预措施

Weekly IFA

Experimental

Receive weekly IFA

干预措施: Iron and folic acid (IFA) (Dietary Supplement)

Daily MMS

Experimental

Receive daily MMS (including iron and folic acid as components)

干预措施: Multiple Micronutrient Supplement (MMS) (Dietary Supplement)

Control

No Intervention

结局指标

主要结局

Anemia status

时间窗: Up to one year

Anemia will be defined based on the sex- and age- specific WHO cutoffs: 1. Children 12-14 years: \< 120 g/L 2. Non-pregnant women ≥ 15 years: \< 120 g/L 3. Pregnant women: \< 110 g/L 4. Men ≥ 15 years: \< 130 g/L

次要结局

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