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
  Purpose

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


Condition Intervention
Dysentery
Diarrhoea
Other: SODIS Bottle

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

Resource links provided by NLM:


Further study details as provided by Royal College of Surgeons, Ireland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2400
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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
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)

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 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.
  Eligibility

Ages Eligible for Study:   12 Months 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

Exclusion Criteria:

  • Chlorinated piped water source available in 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: NCT01306383

Locations
Cambodia
CIC
Phnom Penh, Cambodia
Kenya
ICROSS
Nairobi, Ngong Hills, Kenya, POBox 507
Zimbabwe
IWSD
Harare, Mount Pleasant, Zimbabwe, MO422
Sponsors and Collaborators
Royal College of Surgeons, Ireland
ICROSS, Kenya
International Water and Sanitation Development (IWSD), Zimbabwe
CARE International - Cambodia (CIC), Cambodia
Investigators
Principal Investigator: Kevin G McGuigan, PhD RCSI
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Kevin McGuigan PhD BSc FInstP / Project Coordinator, Royal College of Surgeons in Ireland (RCSI)
ClinicalTrials.gov Identifier: NCT01306383     History of Changes
Other Study ID Numbers: SODISWATER EU 031650, SODIS Kenya, Zimbab, Cambodia
Study First Received: February 28, 2011
Last Updated: November 9, 2011
Health Authority: Kenya: Ministry of Health
Zimbabwe: Medical Research Council
Cambodia: Ministry of Health

Keywords provided by Royal College of Surgeons, Ireland:
SODIS
waterborne
Disease
Diarrhoea
dysentery

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 29, 2014