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Pakistan Flocculent Health Outcome Study

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ClinicalTrials.gov Identifier: NCT01538953
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : February 27, 2012
Sponsor:
Collaborators:
Health Oriented Preventive Education
Procter and Gamble
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
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 or disease Intervention/treatment
Diarrhea Other: handwashing Other: flocculent-disinfectant for water treatment Other: water treatment with sodium hypochlorite

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8949 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pakistan Flocculent Health Outcome Study
Study Start Date : March 2003
Primary Completion Date : December 2003
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. diarrhea longitudinal prevalence


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538953


Locations
Pakistan
Health-Oriented Preventive Education
Karachi, Pakistan
Sponsors and Collaborators
Centers for Disease Control and Prevention
Health Oriented Preventive Education
Procter and Gamble

Publications:
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
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012

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