Pakistan Flocculent Health Outcome Study

Diarrhea Clinical Trial

Official title:

Pakistan Flocculent Health Outcome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538953
• Other study ID #: CDC3794
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: February 24, 2012
• Start date: March 2003
• Est. completion date: January 2004

Study information

• Verified date: February 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8949
• Est. completion date: January 2004
• Est. primary completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea

Intervention

Other:
• handwashing
participants received weekly in-home handwashing promotion and soap as needed
• flocculent-disinfectant for water treatment
participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it
• water treatment with sodium hypochlorite
participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it

Locations

Country	Name	City	State
Pakistan	Health-Oriented Preventive Education	Karachi

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Health Oriented Preventive Education, Procter and Gamble

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Boudier E, Zurlinden B, Cour A, Rognon M, Devalland-Monnin C, Nirhy-Lanto A, el Khadissi H. [Antenatal diagnosis of achondrogenesis. Two successive cases in the same family]. J Gynecol Obstet Biol Reprod (Paris). 1991;20(5):623-6. French. — View Citation

Luby SP, Agboatwalla M, Painter J, Altaf A, Billhimer W, Keswick B, Hoekstra RM. Combining drinking water treatment and hand washing for diarrhoea prevention, a cluster randomised controlled trial. Trop Med Int Health. 2006 Apr;11(4):479-89. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diarrhea longitudinal prevalence