Bhubaneswar, Odisha, India
NCT Number: NCT01202383
Double-blinded Trial of Household-based Chlorination in India
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Household-based water treatment with NADCC tablets
BehavioralStudy participants will be supplied with tablets and encouraged to use them for treating their water daily
Household-based water treatment with placebo tablets
BehavioralStudy participants will be supplied with tablets and encouraged to use them for treating their water daily
Primary outcomes
-
diarrhoea morbidity
Time frame: monthly visits for 12 months
diarrhoea will be recorded among <5s and all ages
Secondary outcomes
-
weight for age Z-score
Time frame: monthly visits for 12 months
weight will be measured among <5s
-
bacteriological water quality in household storage container
Time frame: monthly visits for 12 months
-
residual chlorine in household storage container
Time frame: monthly visits for 12 months
-
absenteeism from school and work
Time frame: monthly visits over 12 months
-
health care expenditure for diarrhea
Time frame: One time visit
Sponsors and collaborators
Lead sponsor
London School of Hygiene and Tropical Medicine
Other
Collaborators
- Chemical Council of America
- Indian Institute of Health Management Research
- Medentech
- Partners for Affordable Technologies in Health
- Population Services International
- United States Agency for International Development (USAID)
Registry information
Official study title
Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Sep 15, 2010
- Registry last updated
- Jun 19, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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