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

This study has been completed.
Sponsor:
Collaborators:
ICROSS, Kenya
International Water and Sanitation Development (IWSD), Zimbabwe
CARE International - Cambodia (CIC), Cambodia
Information provided by:
Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier:
NCT01306383
First received: February 28, 2011
Last updated: November 9, 2011
Last verified: February 2011

February 28, 2011
November 9, 2011
June 2008
October 2009   (final data collection date for primary outcome measure)
  • Dysentery disease rate [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of diarrhoea and numbers of diarrhoeal episodes was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks.
Same as current
Complete list of historical versions of study NCT01306383 on ClinicalTrials.gov Archive Site
Height and weight benefit [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Anthropometric measurements of height and weight were recorded at 3 month intervals across the 12 month study period.
Same as current
Not Provided
Not Provided
 
Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations
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

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

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:

  1. 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).
  2. 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).
  3. Demonstration of the effectiveness of SODIS at household level.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Dysentery
  • Diarrhoea
Other: SODIS Bottle
SODIS Bottles used by SODIS group to treat their drinking water
Other Name: Unused 2-litre PET bottles (e.g. Coca-Cola, Pepsi)
  • Active Comparator: SODIS Bottles given
    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.
    Intervention: Other: SODIS Bottle
  • Active Comparator: Usual practices
    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: Other: SODIS Bottle

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2400
May 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
12 Months to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Cambodia,   Kenya,   Zimbabwe
 
NCT01306383
SODISWATER EU 031650, SODIS Kenya, Zimbab, Cambodia
No
Dr Kevin McGuigan PhD BSc FInstP / Project Coordinator, Royal College of Surgeons in Ireland (RCSI)
Royal College of Surgeons, Ireland
  • ICROSS, Kenya
  • International Water and Sanitation Development (IWSD), Zimbabwe
  • CARE International - Cambodia (CIC), Cambodia
Principal Investigator: Kevin G McGuigan, PhD RCSI
Royal College of Surgeons, Ireland
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP