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Clinical Trials/NCT01202383
NCT01202383CompletedPhase 3

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 site in 1 country2,163 target enrollmentStarted: October 2010Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Clasen

Dr

London School of Hygiene and Tropical Medicine

Study Sites (1)

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