Solar Disinfection of Drinking Water (SODISWATER)
|First Received Date ICMJE||March 5, 2010|
|Last Updated Date||March 5, 2010|
|Start Date ICMJE||October 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
The method comprises pictorial or smiley diaries that record diarrhoea consistent with the World Health Organisation definition: three or more loose or watery stools in a 24-hour period and/or stools containing blood or mucus.The smiley diary allows a person to note any diarrhoeal episodes themselves on a recording form on a daily basis. The happy face is marked by the parent or carer when the child passes a normal stool. If a loose or watery stool is passed by the child, one of the sad faces is marked, and if the child passes blood or mucus in his or her stools the special box is marked.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Solar Disinfection of Drinking Water|
|Official Title ICMJE||Solar Disinfection of Drinking Water for Use in Developing Countries or in Emergency Situations|
SODISWATER is a European Union funded health impact assessment study investigating the effect of sunlight to inactivate microbial pathogens in drinking water. This study was done by observing whether children younger than 5 years old who drink solar disinfected water were healthier than those who did not. Health was measured by how often the children had diarrhoea.
Participants were given plastic bottles to place in the sun, water samples were then collected from these plastic bottles to be analyzed. They were also requested to fill in diarrhea diaries.
TESTABLE RESEARCH HYPOTHESES:
Health Impact Assessment: Children who use solar disinfected water will have:
(a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden (g) increased school attendance
The current evidence base for solar disinfection in the prevention of diarrhoeal disease in children rests on three published studies. All share two significant weaknesses: all were carried out in Kenya, in communities which have very high incidences of diarrhoeal disease and water characterised by high levels of both turbidity and microbial contamination. Furthermore, neither of the studies of diarrhoeal disease distinguished between dysentery (associated with significant risk of mortality) and other sorts of diarrhoea, which carry a far lower risk. The present study will extend the evidence base into communities at lower risk and with higher water quality. Furthermore, by using pictorial diaries, dysentery can be analysed as a specific health endpoint. Diarrhoea will be recorded consistent with the World Health organisation definition: three or more loose or watery stools in a 24-hour period and/or stools containing blood or mucus.
AIM OF THE PROJECT IN RELATION TO HEALTH IMPACT ASSESSMENT STUDIES:
The primary aim of the SODISWATER PROJECT is to demonstrate that SODIS is an appropriate intervention against diarrhoeal and waterborne disease among communities in developing countries and those affected by natural or man-made disasters by conducting multi-centred epidemiologically controlled Health Impact Assessments of the SODIS technique across the African Continent under a variety of social, geographical and climactic conditions.
SCIENTIFIC OBJECTIVES OF SODISWATER IN RELATION TO HEALTH IMPACT ASSESSMENT STUDIES:
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Intervention ICMJE||Other: Solar disinfection in transparent containers (plastic bottles)
Participants in the study drink solar disinfected (SODIS) water. Solar disinfected water is water (> 3 L) that has been placed in direct sunlight for 6 hours. Participants are expected to drink SODIS treated water for the duration of the study.
|Study Arm (s)||Solar disinfection of drinking water
Intervention: Other: Solar disinfection in transparent containers (plastic bottles)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||up to 5 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||South Africa|
|Removed Location Countries|
|NCT Number ICMJE||NCT01082107|
|Other Study ID Numbers ICMJE||EU 031650|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Martella du Preez Senior Ms, CSIR|
|Study Sponsor ICMJE||Council for Scientific and Industrial Research, South Africa|
|Information Provided By||Council for Scientific and Industrial Research, South Africa|
|Verification Date||June 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP