Clinical trial NCT01376440: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Diarrhoea
Keywords: three or more loss stools in 24 hours
Lead sponsor: Haramaya Unversity
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 845
Sex: ALL
Minimum age (years): 1
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?


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

Primary outcomes:
measure: To assess the prevalence of diarrhea among under five children
timeFrame: four months
Secondary outcomes:
measure: To assess the weight gain among the intervention and control groups of under five children
timeFrame: At the beginning and end of the study ( 4 months interval)
measure: Residual chlorine test
timeFrame: four months
Other outcomes:
Locations:
city: Kersa
country: Ethiopia
facility: Kersa district
state: Eastern Hararage
Study officials:
affiliation: Assistant professor
name: Bezatu M Alemu, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
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.