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Double-blinded Trial of Household-based Chlorination in India

This study has been completed.
Sponsor:
Collaborators:
Population Services International
Partners for Affordable Technologies in Health
United States Agency for International Development (USAID)
Chemical Council of America
Medentech Ltd.
Indian Institute of Health Management Research
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01202383
First received: September 14, 2010
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diarrhoea
 Behavioral: Household-based water treatment with NADCC tablets
Behavioral: Household-based water treatment with placebo tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • diarrhoea morbidity [ Time Frame: monthly visits for 12 months ] [ Designated as safety issue: No ]
    diarrhoea will be recorded among <5s and all ages


Secondary Outcome Measures:
  • weight for age Z-score [ Time Frame: monthly visits for 12 months ] [ Designated as safety issue: No ]
    weight will be measured among <5s

  • bacteriological water quality in household storage container [ Time Frame: monthly visits for 12 months ] [ Designated as safety issue: No ]
  • residual chlorine in household storage container [ Time Frame: monthly visits for 12 months ] [ Designated as safety issue: No ]
  • absenteeism from school and work [ Designated as safety issue: No ]
  • health care expenditure for diarrhea [ Designated as safety issue: No ]

Enrollment: 2163
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NADCC tablets 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
Placebo Comparator: Placebo tablets 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

  Eligibility

Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202383

Locations
India
Bhubaneswar, Orissa, India
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Population Services International
Partners for Affordable Technologies in Health
United States Agency for International Development (USAID)
Chemical Council of America
Medentech Ltd.
Indian Institute of Health Management Research
Investigators
Principal Investigator: Thomas Clasen, PhD London School of Hygiene and Tropical Medicine
  More Information

No publications provided

Responsible Party: Thomas Clasen, Senior Lecturer, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01202383     History of Changes
Other Study ID Numbers: EH224
Study First Received: September 14, 2010
Last Updated: February 6, 2012
Health Authority: United Kingdom: Research Ethics Committee
India: Institute of Health Management Research

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Troclosene
Antifungal Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Disinfectants

ClinicalTrials.gov processed this record on May 16, 2013