Double-blinded Trial of Household-based Chlorination in India

NCT01202383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2163

Last updated 2013-06-19

No results posted yet for this study

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.

Conditions

  • Diarrhoea

Interventions

BEHAVIORAL

Household-based water treatment with NADCC tablets

Study participants will be supplied with tablets and encouraged to use them for treating their water daily

BEHAVIORAL

Household-based water treatment with placebo tablets

Study participants will be supplied with tablets and encouraged to use them for treating their water daily

Sponsors & Collaborators

  • Population Services International

    collaborator OTHER
  • Partners for Affordable Technologies in Health

    collaborator UNKNOWN
  • United States Agency for International Development (USAID)

    collaborator FED
  • Chemical Council of America

    collaborator UNKNOWN
  • Medentech

    collaborator INDUSTRY
  • Indian Institute of Health Management Research

    collaborator UNKNOWN
  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Thomas Clasen, PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202383 on ClinicalTrials.gov