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Acceptability and Effectiveness of Household Water Treatment in Reducing Diarrhea Among Under Five Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bezatu Mengiste, Haramaya Unversity
ClinicalTrials.gov Identifier:
NCT01376440
First received: June 16, 2011
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

The Millenium development goals (MDGs) call for reducing by half the proportion of people without sustainable access to safe drinking water. This goal was adopted in large part because safe drinking water has been seen as critical to fighting diarrheal disease. Source protection is considered the main intervention area to achieve this goal. However, research worldwide that has shown that even drinking water which is safe at the source is subject to frequent and extensive fecal contamination during collection, storage and use in the home. This contamination is through the introduction of cups, dippers or hands, contamination by flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can pose infectious disease risks if they become contaminated due to unsanitary collection, storage conditions and practices within households.

To reduce this problem, point-of-use water treatment has been advocated as a means to substantially decrease the global burden of diarrhea and to contribute to the MDGs. However, research indicates that there are many unanswered questions around Household water treatment (HWT) that require small or medium scale epidemiological studies and randomized controlled trials, especially with regard to effectiveness, acceptability and identifying suitable target populations. Some of the most urgent questions to be resolved are:(1) How much of the currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted? (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease is high.

hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive children? hypothesis: Do household water treatment with chlorine acceptable in the community?


Condition Intervention Phase
Acute Diarrhoea
 Other: household water treatment
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Acceptability and Effectiveness of Household Water Chlorination in Reducing the Prevalence of Diarrhea Among Under Five Children in Eastern Ethiopia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haramaya Unversity:

Primary Outcome Measures:
  • To assess the prevalence of diarrhea among under five children [ Time Frame: four months ] [ Designated as safety issue: Yes ]
    weekly visit of the household for the presence of diarrhoea among underfive for four months in both the intervention and control groups


Secondary Outcome Measures:
  • To assess the weight gain among the intervention and control groups of under five children [ Time Frame: At the beginning and end of the study ( 4 months interval) ] [ Designated as safety issue: Yes ]
    This is designed to assess whether there is weight gain (objective outcome) in children assigned to the intervention group compared to the control group. It is supplement to the prevalence of diarrhea which is subjective outcome for this study

  • Residual chlorine test [ Time Frame: four months ] [ Designated as safety issue: Yes ]
    The use of the intervention (1.25% hypochlorite) is confirmed by the testing the residual chlorine weekly for for months from each household assigned in the intrevention group


Enrollment: 845
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Household water treatment
household water treatment with 1.25% sodium hypochlorite
 Other: household water treatment
household water treatment with 1.25% sodium hypochlorite
Other Name: 1.25% sodium hypochlorite
No Intervention: control
Usual practice (the use of "Jerrican" for water storage, which is considered as safe storage)

  Eligibility

Ages Eligible for Study:   1 Month to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children under five years of age in the randomly selected clusters of Kersa district

Exclusion Criteria:

  • seriously sick children in the randomly selected clusters of Kersa district
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376440

Locations
Ethiopia
Kersa district
Kersa, Eastern Hararage, Ethiopia, 235
Sponsors and Collaborators
Haramaya Unversity
Investigators
Principal Investigator: Bezatu M Alemu, M.Sc Assistant professor
  More Information

No publications provided

Responsible Party: Bezatu Mengiste, Mr, Haramaya Unversity
ClinicalTrials.gov Identifier: NCT01376440     History of Changes
Other Study ID Numbers: SGS13/15/11
Study First Received: June 16, 2011
Last Updated: January 23, 2012
Health Authority: Ethiopia: Ethical Review Committee

Keywords provided by Haramaya Unversity:
three or more loss stools in 24 hours

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

ClinicalTrials.gov processed this record on June 17, 2013