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

Diarrhoea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306383
• Other study ID #: SODISWATER EU 031650
• Secondary ID: SODIS Kenya, Zim
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: November 9, 2011
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: February 2011
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ministry of HealthZimbabwe: Medical Research CouncilCambodia: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: May 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea
• Dysentery

Intervention

Other:
• SODIS Bottle
SODIS Bottles used by SODIS group to treat their drinking water

Locations

Country	Name	City	State
Cambodia	CIC	Phnom Penh
Kenya	ICROSS	Nairobi	Ngong Hills
Zimbabwe	IWSD	Harare	Mount Pleasant

Sponsors (4)

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

Countries where clinical trial is conducted

Cambodia,  Kenya,  Zimbabwe, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Ubomba-Jaswa E, Fernández-Ibáñez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month	No
Primary	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.	12 months	No
Secondary	Height and weight benefit	Anthropometric measurements of height and weight were recorded at 3 month intervals across the 12 month study period.	12 months	No

External Links

•   Information site for SODIS
•   SODISWATER project website