Double-blinded Trial of Household-based Chlorination in India

June 18, 2013 updated by: Thomas Clasen, London School of Hygiene and Tropical Medicine

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

2163

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Orissa
      • Bhubaneswar, Orissa, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Approximately 2000 households with children <5 will be enrolled.

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo tablets
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
Active Comparator: NADCC tablets
Study participants will be supplied with tablets and encouraged to use them for treating their water daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diarrhoea morbidity
Time Frame: monthly visits for 12 months
diarrhoea will be recorded among <5s and all ages
monthly visits for 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight for age Z-score
Time Frame: monthly visits for 12 months
weight will be measured among <5s
monthly visits for 12 months
bacteriological water quality in household storage container
Time Frame: monthly visits for 12 months
monthly visits for 12 months
residual chlorine in household storage container
Time Frame: monthly visits for 12 months
monthly visits for 12 months
absenteeism from school and work
Time Frame: monthly visits over 12 months
monthly visits over 12 months
health care expenditure for diarrhea
Time Frame: One time visit
One time visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diarrhoea

Clinical Trials on Household-based water treatment with NADCC tablets

3
Subscribe