Pakistan Flocculent Health Outcome Study

This study has been completed.
Sponsor:
Collaborators:
Health Oriented Preventive Education
Procter and Gamble
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01538953
First received: February 21, 2012
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

This study is designed to evaluate the effect of different methods of drinking water treatment on the occurrence of diarrhea among children living in squatter settlements in Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260 households will receive a new product which combines flocculation with chlorination to produce clearer, less chemically contaminated drinking water. 260 households will receive dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive soap and encouraged to wash their hands regularly. 260 households will receive both soap and the combination flocculation/chlorination water treatment. 260 households will continue their standard water treatment and handwashing practices. The households will be visited each week for 9 months, and the episodes of diarrhea from each child in the household recorded. The rate of diarrhea between the groups will be compared. At the end of 9 months, households who were part of the standard habits and practice group will receive a water storage vessel and disinfectant.


Condition Intervention
Diarrhea
Other: handwashing
Other: flocculent-disinfectant for water treatment
Other: water treatment with sodium hypochlorite

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pakistan Flocculent Health Outcome Study

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • diarrhea longitudinal prevalence

Enrollment: 8949
Study Start Date: March 2003
Study Completion Date: January 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Handwashing
participants received weekly, in-home handwashing promotion and soap as needed
Other: handwashing
participants received weekly in-home handwashing promotion and soap as needed
Experimental: handwashing and water treatment Other: handwashing
participants received weekly in-home handwashing promotion and soap as needed
Other: flocculent-disinfectant for water treatment
participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it
Experimental: Water treatment with sodium hypochlorite Other: water treatment with sodium hypochlorite
participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it
Experimental: Water treatment with flocculent-disinfectant
participants received a supply of flocculent-disinfectant product and instruction to use it to treat drinking water
Other: flocculent-disinfectant for water treatment
participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it
No Intervention: Control

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • households in study neighborhoods
  • contain a child < 5 years old
  • have access to water for handwashing

Exclusion Criteria:

  • participated in handwashing or drinking water treatment programs with HOPE previously
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538953

Locations
Pakistan
Health-Oriented Preventive Education
Karachi, Pakistan
Sponsors and Collaborators
Health Oriented Preventive Education
Procter and Gamble
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01538953     History of Changes
Other Study ID Numbers: CDC3794
Study First Received: February 21, 2012
Last Updated: February 24, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
diarrhea
handwashing
point-of-use water treatment
diarrhea longitudinal prevalence

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Sodium Hypochlorite
Disinfectants
Eusol
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014