School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar
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
- 是
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
Receive weekly IFA
干预措施: Iron and folic acid (IFA) (Dietary Supplement)
Daily MMS
Receive daily MMS (including iron and folic acid as components)
干预措施: Multiple Micronutrient Supplement (MMS) (Dietary Supplement)
Control
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
Wafaie Fawzi
Professor of Nutrition, Epidemiology, and Global Health
Harvard School of Public Health (HSPH)
