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Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations (SODISWATER)

Primary Purpose

Dysentery, Diarrhoea

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SODIS Bottle
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysentery focused on measuring SODIS, waterborne, Disease, Diarrhoea, dysentery

Eligibility Criteria

12 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Chlorinated piped water source available in household

Sites / Locations

  • CIC
  • ICROSS
  • IWSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SODIS Bottles given

Usual practices

Arm Description

Caregivers in the intervention group were given two 2-litre plastic bottles. Bottle was filled with available water and placed in direct sunlight for a minimum of 6 hours. Water was consumed the next day while second bottle was being consumed.

Caregivers in this group were asked to maintain their usual practices regarding drinking water so that disease rates could be compared with the SODIS arm

Outcomes

Primary Outcome Measures

Dysentery disease rate
Incidence of occurrence of blood or mucous in diarrhoeal stools was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks.
Diarrhoea disease rate
Incidence of diarrhoea and numbers of diarrhoeal episodes was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks.

Secondary Outcome Measures

Height and weight benefit
Anthropometric measurements of height and weight were recorded at 3 month intervals across the 12 month study period.

Full Information

First Posted
February 28, 2011
Last Updated
November 9, 2011
Sponsor
Royal College of Surgeons, Ireland
Collaborators
ICROSS, Kenya, International Water and Sanitation Development (IWSD), Zimbabwe, CARE International - Cambodia (CIC), Cambodia
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1. Study Identification

Unique Protocol Identification Number
NCT01306383
Brief Title
Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations
Acronym
SODISWATER
Official Title
Assessment of the Health Benefits Associated With Consumption of Solar Disinfection of Drinking Water by Children Under Age 5 Years, With Particular Emphasis on Dysentery and Childhood Diarrhoea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royal College of Surgeons, Ireland
Collaborators
ICROSS, Kenya, International Water and Sanitation Development (IWSD), Zimbabwe, CARE International - Cambodia (CIC), Cambodia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
SODISWATER was a health impact assessment study investigating the effect of sunlight to inactivate microbial pathogens in drinking water. This study was carried out 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 or dysentery. Caregivers for the 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 3 countries (Kenya, Zimbabwe and Cambodia). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysentery, Diarrhoea
Keywords
SODIS, waterborne, Disease, Diarrhoea, dysentery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SODIS Bottles given
Arm Type
Active Comparator
Arm Description
Caregivers in the intervention group were given two 2-litre plastic bottles. Bottle was filled with available water and placed in direct sunlight for a minimum of 6 hours. Water was consumed the next day while second bottle was being consumed.
Arm Title
Usual practices
Arm Type
Active Comparator
Arm Description
Caregivers in this group were asked to maintain their usual practices regarding drinking water so that disease rates could be compared with the SODIS arm
Intervention Type
Other
Intervention Name(s)
SODIS Bottle
Other Intervention Name(s)
Unused 2-litre PET bottles (e.g. Coca-Cola, Pepsi)
Intervention Description
SODIS Bottles used by SODIS group to treat their drinking water
Primary Outcome Measure Information:
Title
Dysentery disease rate
Description
Incidence of occurrence of blood or mucous in diarrhoeal stools was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks.
Time Frame
12 month
Title
Diarrhoea disease rate
Description
Incidence of diarrhoea and numbers of diarrhoeal episodes was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Height and weight benefit
Description
Anthropometric measurements of height and weight were recorded at 3 month intervals across the 12 month study period.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
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 Exclusion Criteria: Chlorinated piped water source available in household
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G McGuigan, PhD
Organizational Affiliation
RCSI
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIC
City
Phnom Penh
Country
Cambodia
Facility Name
ICROSS
City
Nairobi
State/Province
Ngong Hills
ZIP/Postal Code
POBox 507
Country
Kenya
Facility Name
IWSD
City
Harare
State/Province
Mount Pleasant
ZIP/Postal Code
MO422
Country
Zimbabwe

12. IPD Sharing Statement

Citations:
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
background
PubMed Identifier
20705982
Citation
Ubomba-Jaswa E, Fernandez-Ibanez P, McGuigan KG. A preliminary Ames fluctuation assay assessment of the genotoxicity of drinking water that has been solar disinfected in polyethylene terephthalate (PET) bottles. J Water Health. 2010 Dec;8(4):712-9. doi: 10.2166/wh.2010.136. Epub 2010 Apr 13.
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
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
21936492
Citation
du Preez M, Conroy RM, Ligondo S, Hennessy J, Elmore-Meegan M, Soita A, McGuigan KG. Randomized intervention study of solar disinfection of drinking water in the prevention of dysentery in Kenyan children aged under 5 years. Environ Sci Technol. 2011 Nov 1;45(21):9315-23. doi: 10.1021/es2018835. Epub 2011 Oct 5.
Results Reference
derived
Links:
URL
http://www.rcsi.ie/sodis
Description
SODISWATER project website
URL
http://www.sodis.ch
Description
Information site for SODIS

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Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations

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