An Efficacy Trial of a Gravity-fed Household Water Treatment Device as a Delivery System for Zinc in Zinc Deficient Preschool Children and Pregnant Women From Rural Settings With Poor Access to Potable Water in Benin.
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Zinc status
研究概览
简要总结
The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations in developing country rural settings with poor access to potable water.
To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc enriched water) a double blind controlled field efficacy trial will take place over a period of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc enriching filter), placebo (filter) and control group (disinfection tables). During the trial the following outcomes will be monitored: zinc status and growth rate of the participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment of water, and modality and consistency of use of the LSF-device by the study population.
The study hypotheses are: 1) the use of the LSF-device will reduce microbiological contamination of the household water, 2) the use of the LSF-device will increase zinc intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device will increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea episodes in participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy outcome and lower frequency and length of diarrhea episodes in participating pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea episodes in participating households members.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-5 year old children
- •subjects residing in the study area for the whole study period
排除标准
- •subject with severe anemia (Hb < 7 g/dl)
- •subjects affected by chronic medical illnesses known to interact with zinc metabolism
- •subjects receiving zinc supplementation or other medicines that may affect zinc metabolism
结局指标
主要结局
Zinc status
时间窗: 12 months
At baseline, endpoint and at a randomly assigned screening between month 1 and 11, a 6 ml whole blood sample will be collected by venipuncture in 2-5y children (N=270). The blood sample will be used to determine concentration of zinc in the serum (SZn). Inflammation indicator C-reactive protein (CRP) will be analysed to adjust SZn values.
次要结局
- Gut microbiota characterisation(2 months)
- Iron status(12 months)
- Growth rate(12 months)
- Diarrhea prevalence(12 months)
研究者
Prof. Michael B. Zimmermann
Prof
Swiss Federal Institute of Technology