Double-blinded Trial of Household-based Chlorination in India
Primary Purpose
Diarrhoea
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Household-based water treatment with NADCC tablets
Household-based water treatment with placebo tablets
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhoea
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
NADCC tablets
Placebo tablets
Arm Description
Outcomes
Primary Outcome Measures
diarrhoea morbidity
diarrhoea will be recorded among <5s and all ages
Secondary Outcome Measures
weight for age Z-score
weight will be measured among <5s
bacteriological water quality in household storage container
residual chlorine in household storage container
absenteeism from school and work
health care expenditure for diarrhea
Full Information
NCT ID
NCT01202383
First Posted
September 14, 2010
Last Updated
June 18, 2013
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Population Services International, Partners for Affordable Technologies in Health, United States Agency for International Development (USAID), Chemical Council of America, Medentech, Indian Institute of Health Management Research
1. Study Identification
Unique Protocol Identification Number
NCT01202383
Brief Title
Double-blinded Trial of Household-based Chlorination in India
Official Title
Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Population Services International, Partners for Affordable Technologies in Health, United States Agency for International Development (USAID), Chemical Council of America, Medentech, Indian Institute of Health Management Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NADCC tablets
Arm Type
Active Comparator
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Household-based water treatment with NADCC tablets
Intervention Description
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
Intervention Type
Behavioral
Intervention Name(s)
Household-based water treatment with placebo tablets
Intervention Description
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
Primary Outcome Measure Information:
Title
diarrhoea morbidity
Description
diarrhoea will be recorded among <5s and all ages
Time Frame
monthly visits for 12 months
Secondary Outcome Measure Information:
Title
weight for age Z-score
Description
weight will be measured among <5s
Time Frame
monthly visits for 12 months
Title
bacteriological water quality in household storage container
Time Frame
monthly visits for 12 months
Title
residual chlorine in household storage container
Time Frame
monthly visits for 12 months
Title
absenteeism from school and work
Time Frame
monthly visits over 12 months
Title
health care expenditure for diarrhea
Time Frame
One time visit
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Clasen, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
City
Bhubaneswar
State/Province
Orissa
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
23976883
Citation
Boisson S, Stevenson M, Shapiro L, Kumar V, Singh LP, Ward D, Clasen T. Effect of household-based drinking water chlorination on diarrhoea among children under five in Orissa, India: a double-blind randomised placebo-controlled trial. PLoS Med. 2013 Aug;10(8):e1001497. doi: 10.1371/journal.pmed.1001497. Epub 2013 Aug 20.
Results Reference
derived
Learn more about this trial
Double-blinded Trial of Household-based Chlorination in India
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