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临床试验/NCT01202383
NCT01202383已完成3 期

Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 2,163 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
2,163
试验地点
1
主要终点
diarrhoea morbidity

研究概览

简要总结

The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to determine if the impact of treating water with chlorine at the household level is effective in preventing diarrhea among young children. For more than a century, chlorine has be used to treat water in municipal systems in developed countries. Lack of infrastructure has prevented its use in lower-income settings. NaDCC is a tablet form of chlorine that has been used for more than 30 years in emergencies and has recently been approved for routine treatment of drinking water by the WHO and US Environmental Protection Agency. The placebo will consist of the food-grade ingredients in the effective tablet, without the chlorine. Study participants will be supplied with tablets (intervention or placebo) and instructed to use the same to treat their water daily. Monthly follow-up visits will assess diarrhoea morbidity and weight-for-age Z scores in <5s. Chlorine residual and bacteriological quality of water stored in the home will be measured each month. The study will also assess the impact of the intervention on absenteeism from school and work and on health care expenditure for diarrhoea.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Households with at least one child< 5
  • Male and female head of household consent to participate
  • Reside permanently in study area

排除标准

  • 未提供

结局指标

主要结局

diarrhoea morbidity

时间窗: monthly visits for 12 months

diarrhoea will be recorded among \<5s and all ages

次要结局

  • weight for age Z-score(monthly visits for 12 months)
  • bacteriological water quality in household storage container(monthly visits for 12 months)
  • residual chlorine in household storage container(monthly visits for 12 months)
  • absenteeism from school and work(monthly visits over 12 months)
  • health care expenditure for diarrhea(One time visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Clasen

Dr

London School of Hygiene and Tropical Medicine

研究点 (1)

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