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Completed

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bhubaneswar, Odisha, India

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

Behavioral

Study participants will be supplied with tablets and encouraged to use them for treating their water daily

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

Primary outcomes

  1. diarrhoea morbidity

    Time frame: monthly visits for 12 months

    diarrhoea will be recorded among <5s and all ages

Secondary outcomes

  1. weight for age Z-score

    Time frame: monthly visits for 12 months

    weight will be measured among <5s

  2. bacteriological water quality in household storage container

    Time frame: monthly visits for 12 months

  3. residual chlorine in household storage container

    Time frame: monthly visits for 12 months

  4. absenteeism from school and work

    Time frame: monthly visits over 12 months

  5. 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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