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
Verified date | January 2012 |
Source | Haramaya Unversity |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ethiopia: Ethical Review Committee |
Study type | Interventional |
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?
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Ethiopia | Kersa district | Kersa | Eastern Hararage |
Lead Sponsor | Collaborator |
---|---|
Haramaya Unversity |
Ethiopia,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02704091 -
Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults
|
Phase 4 |