Double-blinded Trial of Household-based Chlorination in India

NCT01202383 | Completed Phase 3 DMC

• 1 other identifier: EH224
• Study Type: interventional
• Target: 2,163
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoea

Outcome Measures

Primary Outcomes (1)

• diarrhoea morbidity

  diarrhoea will be recorded among \<5s and all ages

  monthly visits for 12 months

Secondary Outcomes (5)

• weight for age Z-score

  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

Study Arms (2)

NADCC tablets

ACTIVE COMPARATOR

Behavioral: Household-based water treatment with NADCC tablets

Placebo tablets

PLACEBO COMPARATOR

Behavioral: Household-based water treatment with placebo tablets

Interventions

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

NADCC tablets

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

Placebo tablets

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Households with at least one child\< 5
• Male and female head of household consent to participate
• Reside permanently in study area

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Population Services International: collaborator
• Partners for Affordable Technologies in Health: collaborator
• United States Agency for International Development (USAID): collaborator
• Chemical Council of America: collaborator
• Medentech: collaborator
• Indian Institute of Health Management Research: collaborator

Study Sites (1)

Unknown Facility

Bhubaneswar, Odisha, India

Location

Related Publications (1)

• 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.

  PMID: 23976883 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Clasen, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

IN (1)