Acceptability and Effectiveness of Household Water Treatment in Reducing Diarrhea Among Under Five Children
Primary Purpose
Acute Diarrhoea
Status
Completed
Phase
Phase 1
Locations
Ethiopia
Study Type
Interventional
Intervention
household water treatment
Sponsored by
About this trial
This is an interventional prevention trial for Acute Diarrhoea focused on measuring three or more loss stools in 24 hours
Eligibility 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
Sites / Locations
- Kersa district
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Household water treatment
control
Arm Description
household water treatment with 1.25% sodium hypochlorite
Usual practice (the use of "Jerrican" for water storage, which is considered as safe storage)
Outcomes
Primary Outcome Measures
To assess the prevalence of diarrhea among under five children
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01376440
Brief Title
Acceptability and Effectiveness of Household Water Treatment in Reducing Diarrhea Among Under Five Children
Official Title
Acceptability and Effectiveness of Household Water Chlorination in Reducing the Prevalence of Diarrhea Among Under Five Children in Eastern Ethiopia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haramaya Unversity
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhoea
Keywords
three or more loss stools in 24 hours
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
845 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Household water treatment
Arm Type
Experimental
Arm Description
household water treatment with 1.25% sodium hypochlorite
Arm Title
control
Arm Type
No Intervention
Arm Description
Usual practice (the use of "Jerrican" for water storage, which is considered as safe storage)
Intervention Type
Other
Intervention Name(s)
household water treatment
Other Intervention Name(s)
1.25% sodium hypochlorite
Intervention Description
household water treatment with 1.25% sodium hypochlorite
Primary Outcome Measure Information:
Title
To assess the prevalence of diarrhea among under five children
Description
weekly visit of the household for the presence of diarrhoea among underfive for four months in both the intervention and control groups
Time Frame
four months
Secondary Outcome Measure Information:
Title
To assess the weight gain among the intervention and control groups of under five children
Description
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
Time Frame
At the beginning and end of the study ( 4 months interval)
Title
Residual chlorine test
Description
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
Time Frame
four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bezatu M Alemu, M.Sc
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kersa district
City
Kersa
State/Province
Eastern Hararage
ZIP/Postal Code
235
Country
Ethiopia
12. IPD Sharing Statement
Citations:
PubMed Identifier
24194899
Citation
Mengistie B, Berhane Y, Worku A. Household water chlorination reduces incidence of diarrhea among under-five children in rural Ethiopia: a cluster randomized controlled trial. PLoS One. 2013 Oct 23;8(10):e77887. doi: 10.1371/journal.pone.0077887. eCollection 2013.
Results Reference
derived
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Acceptability and Effectiveness of Household Water Treatment in Reducing Diarrhea Among Under Five Children
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