Solar Disinfection of Drinking Water (SODISWATER)

This study has been completed.
Sponsor:
Collaborators:
Royal College of Surgeons, Ireland
European Union
Information provided by:
Council for Scientific and Industrial Research, South Africa
ClinicalTrials.gov Identifier:
NCT01082107
First received: March 5, 2010
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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


Condition Intervention
Diarrhea
Dysentery (Bloody Diarrhea)
Other: Solar disinfection in transparent containers (plastic bottles)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Solar Disinfection of Drinking Water for Use in Developing Countries or in Emergency Situations

Resource links provided by NLM:


Further study details as provided by Council for Scientific and Industrial Research, South Africa:

Primary Outcome Measures:
  • 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.


Enrollment: 800
Study Start Date: October 2006
Study Completion Date: August 2009
Arms Assigned Interventions
Solar disinfection of drinking water 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.

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:

  1. 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
  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.
  4. Assessment of gender specific issues.
  5. Demonstration of the degree of acceptance/ compliance of SODIS as a disinfection method.
  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presence of one or more children aged less than 5 years in the household
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082107

Locations
South Africa
Council for Scientific and Industrial Research (CSIR)
Pretoria, Gauteng, South Africa, 0001
Sponsors and Collaborators
Council for Scientific and Industrial Research, South Africa
Royal College of Surgeons, Ireland
European Union
Investigators
Principal Investigator: Kevin G McGuigan, PhD Royal College of Surgeons in Ireland (RCSI)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martella du Preez Senior Ms, CSIR
ClinicalTrials.gov Identifier: NCT01082107     History of Changes
Other Study ID Numbers: EU 031650
Study First Received: March 5, 2010
Last Updated: March 5, 2010
Health Authority: South Africa: Department of Health
South Africa: Human Research Ethics Committee

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014