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Solar Disinfection of Drinking Water (SODISWATER)

Primary Purpose

Diarrhea, Dysentery (Bloody Diarrhea)

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Solar disinfection in transparent containers (plastic bottles)
Sponsored by
Council for Scientific and Industrial Research, South Africa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea

Eligibility Criteria

undefined - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Presence of one or more children aged less than 5 years in the household

Sites / Locations

  • Council for Scientific and Industrial Research (CSIR)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Solar disinfection of drinking water

Arm Description

Outcomes

Primary Outcome Measures

Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old
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.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2010
Last Updated
March 5, 2010
Sponsor
Council for Scientific and Industrial Research, South Africa
Collaborators
Royal College of Surgeons, Ireland, European Union
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1. Study Identification

Unique Protocol Identification Number
NCT01082107
Brief Title
Solar Disinfection of Drinking Water
Acronym
SODISWATER
Official Title
Solar Disinfection of Drinking Water for Use in Developing Countries or in Emergency Situations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Council for Scientific and Industrial Research, South Africa
Collaborators
Royal College of Surgeons, Ireland, European Union

4. Oversight

5. Study Description

Brief Summary
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
Detailed Description
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: Assessment of the change in health reasonably attributed to the provision of solar disinfected drinking water at the point of use in four African countries Assessment of the relationship between solar disinfected drinking water and selected health indicators (including morbidity due to non-bloody diarrhoea and dysentery, weight loss, mortality, growth rates, productivity, care-giver burden, and school attendance. Mortality will also be monitored but the sample sizes are of insufficient size to produce detailed information and scaling up, to account for this is not possible due to prohibitive costs). Demonstration of the effectiveness of SODIS at household level. Assessment of gender specific issues. Demonstration of the degree of acceptance/ compliance of SODIS as a disinfection method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Dysentery (Bloody Diarrhea)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solar disinfection of drinking water
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Solar disinfection in transparent containers (plastic bottles)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old
Description
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.
Time Frame
Duration of the study

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Presence of one or more children aged less than 5 years in the household
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G McGuigan, PhD
Organizational Affiliation
Royal College of Surgeons, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Council for Scientific and Industrial Research (CSIR)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
8973432
Citation
Conroy RM, Elmore-Meegan M, Joyce T, McGuigan KG, Barnes J. Solar disinfection of drinking water and diarrhoea in Maasai children: a controlled field trial. Lancet. 1996 Dec 21-28;348(9043):1695-7. doi: 10.1016/S0140-6736(96)02309-4.
Results Reference
background
PubMed Identifier
10490440
Citation
Conroy RM, Meegan ME, Joyce T, McGuigan K, Barnes J. Solar disinfection of water reduces diarrhoeal disease: an update. Arch Dis Child. 1999 Oct;81(4):337-8. doi: 10.1136/adc.81.4.337.
Results Reference
background
PubMed Identifier
11567937
Citation
Conroy RM, Meegan ME, Joyce T, McGuigan K, Barnes J. Solar disinfection of drinking water protects against cholera in children under 6 years of age. Arch Dis Child. 2001 Oct;85(4):293-5. doi: 10.1136/adc.85.4.293.
Results Reference
background
PubMed Identifier
20977257
Citation
Du Preez M, Mcguigan KG, Conroy RM. Solar disinfection of drinking water in the prevention of dysentery in South African children aged under 5 years: the role of participant motivation. Environ Sci Technol. 2010 Nov 15;44(22):8744-9. doi: 10.1021/es103328j.
Results Reference
derived
Links:
URL
http://www.rcsi.ie/sodis/
Description
Click here for more information on SODISWATER, a research project funded by the European Union (EU) under the 6th Framework Programme (FP6)

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Solar Disinfection of Drinking Water

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