Diarrhoea
Conditions
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.
Interventions
BEHAVIORALHousehold-based water treatment with NADCC tablets
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
BEHAVIORALHousehold-based water treatment with placebo tablets
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
Sponsors
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
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diarrhoea morbidity | monthly visits for 12 months | diarrhoea will be recorded among \<5s and all ages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weight for age Z-score | monthly visits for 12 months | weight will be measured among \<5s |
| bacteriological water quality in household storage container | monthly visits for 12 months | — |
| residual chlorine in household storage container | monthly visits for 12 months | — |
| absenteeism from school and work | monthly visits over 12 months | — |
| health care expenditure for diarrhea | One time visit | — |
Countries
India
Outcome results
None listed