Clinical trial NCT01202383: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhoea
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Population Services International
name: Partners for Affordable Technologies in Health
name: United States Agency for International Development (USAID)
name: Chemical Council of America
name: Medentech
name: Indian Institute of Health Management Research
First posted: 2010-09-15
Enrollment: 2163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: diarrhoea morbidity
timeFrame: monthly visits for 12 months
Secondary outcomes:
measure: weight for age Z-score
timeFrame: monthly visits for 12 months
measure: bacteriological water quality in household storage container
timeFrame: monthly visits for 12 months
measure: residual chlorine in household storage container
timeFrame: monthly visits for 12 months
measure: absenteeism from school and work
timeFrame: monthly visits over 12 months
measure: health care expenditure for diarrhea
timeFrame: One time visit
Other outcomes:
Locations:
city: Bhubaneswar
country: India
state: Orissa
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Thomas Clasen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.