Double-blinded Trial of Household-based Chlorination in India

Diarrhoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202383
• Other study ID #: EH224
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2010
• Last updated: June 18, 2013
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2013
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeIndia: Institute of Health Management Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2163
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhoea

Intervention

Behavioral:
• Household-based water treatment with NADCC tablets
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
• Household-based water treatment with placebo tablets
Study participants will be supplied with tablets and encouraged to use them for treating their water daily

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	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)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diarrhoea morbidity	diarrhoea will be recorded among <5s and all ages	monthly visits for 12 months	No
Secondary	weight for age Z-score	weight will be measured among <5s	monthly visits for 12 months	No
Secondary	bacteriological water quality in household storage container		monthly visits for 12 months	No
Secondary	residual chlorine in household storage container		monthly visits for 12 months	No
Secondary	absenteeism from school and work		monthly visits over 12 months	No
Secondary	health care expenditure for diarrhea		One time visit	No