Efficacy Study of Water as Fortification Vehicle for Zinc for Improving Zinc Status in Primary Schools Children in the Municipality of Natitingou, North of Benin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Zinc status
研究概览
简要总结
The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.
详细描述
A double-blind efficacy study will be carried out over 4 months in school age children enrolled in a primary school equipped with a water pump, in the rural area of the commune of Natitingou, Benin. Participating children will be randomly assigned to one of two groups of intervention or control. On a daily basis, all children will consume a defined quantity of pump-water outside of meals. The water offered to children in the first group of intervention will be previously filtered and zinc-fortified by the LSF-filter; the children in the second group will receive water that has been filtered only. A nutrition survey will provide an indication of dietary zinc intake. The effect of enriched water consumption on children's zinc status will be evaluated by analyzing the concentration of zinc in serum at baseline, midpoint and endpoint of the intervention. Diarrhea rates will be monitored by recording episodes of diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •School aged children enrolled in primary school and regularly attending class
排除标准
- •Severe anemia (Hb < 7 g/dl)
- •Consumption of a supplement or dietary supplement containing zinc
- •Use of drugs that affect the metabolism of zinc
- •Suffering from a chronic disease affecting the metabolism of zinc
结局指标
主要结局
Zinc status
时间窗: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)
Serum zinc concentration
次要结局
- Diarrhea incidence(Weekly, from baseline through to endpoint)
- Malaria prevalence(Baseline, midpoint (varying between weeks 5-20), endpoint (week 22))
- Inflammation status(Baseline, midpoint (varying between weeks 5-20), endpoint (week 22))
- Iron status(Baseline, midpoint (varying between weeks 5-20), endpoint (week 22))
- ALRI prevalence(At baseline and endpoint)
- Anthropometric indices(Baseline, midpoint (varying between weeks 5-20), endpoint (week 22))
研究者
Prof. Michael B. Zimmermann
Prof. Dr.med
Swiss Federal Institute of Technology