- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01202383
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
Status
Completed
Conditions
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.
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