Double-blinded Trial of Household-based Chlorination in India

Study Overview
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Brief Summary
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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.

Official Title
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Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets

Conditions
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Diarrhoea

Intervention / Treatment
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* Behavioral: Household-based water treatment with NADCC tablets
* Behavioral: Household-based water treatment with placebo tablets


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NADCC tablets<br> | Behavioral: Household-based water treatment with NADCC tablets<br>* Study participants will be supplied with tablets and encouraged to use them for treating their water daily<br>|
| Placebo Comparator: Placebo tablets<br> | Behavioral: Household-based water treatment with placebo tablets<br>* Study participants will be supplied with tablets and encouraged to use them for treating their water daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diarrhoea morbidity | 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 | weight will be measured among <5s | monthly visits for 12 months | 
| 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 |