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| Name | Class |
|---|---|
| Population Services International | OTHER |
| Partners for Affordable Technologies in Health | UNKNOWN |
| United States Agency for International Development (USAID) | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NADCC tablets | Active Comparator |
| |
| Placebo tablets | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Household-based water treatment with NADCC tablets | Behavioral | Study participants will be supplied with tablets and encouraged to use them for treating their water daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| diarrhoea morbidity | diarrhoea will be recorded among <5s and all ages | monthly visits for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| weight for age Z-score | weight will be measured among <5s | monthly visits for 12 months |
| bacteriological water quality in household storage container | monthly visits for 12 months |
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Approximately 2000 households with children <5 will be enrolled.
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Clasen, PhD | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bhubaneswar | Odisha | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23976883 | Derived | 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. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Chemical Council of America |
| UNKNOWN |
| Medentech | INDUSTRY |
| Indian Institute of Health Management Research | UNKNOWN |
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| Household-based water treatment with placebo tablets | Behavioral | Study participants will be supplied with tablets and encouraged to use them for treating their water daily |
|
| 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 |