Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 2,163
- Locations
- 1
- Primary Endpoint
- diarrhoea morbidity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Households with at least one child< 5
- •Male and female head of household consent to participate
- •Reside permanently in study area
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
diarrhoea morbidity
Time Frame: monthly visits for 12 months
diarrhoea will be recorded among \<5s and all ages
Secondary Outcomes
- 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)
Investigators
Thomas Clasen
Dr
London School of Hygiene and Tropical Medicine
