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

Acute Diarrhoea Clinical Trial

Official title:

Acceptability and Effectiveness of Household Water Chlorination in Reducing the Prevalence of Diarrhea Among Under Five Children in Eastern Ethiopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376440
• Other study ID #: SGS13/15/11
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2011
• Last updated: January 23, 2012
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Haramaya Unversity
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 845
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 59 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Diarrhoea
• Diarrhea

Intervention

Other:
• household water treatment
household water treatment with 1.25% sodium hypochlorite

Locations

Country	Name	City	State
Ethiopia	Kersa district	Kersa	Eastern Hararage

Sponsors (1)

Lead Sponsor	Collaborator
Haramaya Unversity

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	four months	Yes
Secondary	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	At the beginning and end of the study ( 4 months interval)	Yes
Secondary	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	four months	Yes