DysenterySODISWATERNCT01306383
Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations
A study testing SODIS Bottle in people with Dysentery and Diarrhoea, run by Royal College of Surgeons, Ireland at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 12 months to 5 yearsHealthy volunteers can take part
- What is being tested?
- SODIS Bottle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Presence of one or more children aged less than 5 years in the household
Who cannot join
- Chlorinated piped water source available in household
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
Read more
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
Read the 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.
- Being tested
- SODIS Bottle
- Keywords
- SODIS, waterborne, Disease, Diarrhoea, dysentery
- Medical subject headings
- Dysentery, Diarrhea, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SODIS BottleOther
Also called Unused 2-litre PET bottles (e.g. Coca-Cola, Pepsi)
SODIS Bottles used by SODIS group to treat their drinking water
| Study group | Role | What they receive |
|---|---|---|
| SODIS Bottles given | Active comparator | 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. Receives: Other: SODIS Bottle |
| Usual practices | Active comparator | 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 Receives: Other: SODIS Bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
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.
Measured: 12 months
Secondary outcomes (1)
Height and weight benefit
Anthropometric measurements of height and weight were recorded at 3 month intervals across the 12 month study period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DysenteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- ICROSS, Kenya, International Water and Sanitation Development (IWSD), Zimbabwe, CARE International - Cambodia (CIC), Cambodia
- Investigators
- Kevin G McGuigan, PhD, Principal investigator, RCSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306383
- Sponsor's protocol ID
- SODISWATER EU 031650
- Other IDs
- SODIS Kenya, Zimbab, Cambodia
- Acronym
- SODISWATER
- Status last verified
- Feb 2011
- First submitted
- 28 Feb 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20977257Ubomba-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.
PubMed 20705982Conroy 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.
PubMed 11567937Conroy 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.
PubMed 8973432du 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.
PubMed 21936492
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01306383
- Acronym / sponsor ID
- SODISWATER / SODISWATER EU 031650
- Keywords
- SODIS, waterborne, Disease, Diarrhoea, dysentery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- ICROSS, Kenya, International Water and Sanitation Development (IWSD), Zimbabwe, CARE International - Cambodia (CIC), Cambodia
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SODIS Bottles given | Active comparator | Other: SODIS BottleCaregivers 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. |
| Usual practices | Active comparator | Other: SODIS BottleCaregivers in this group were asked to maintain their usual practices regarding drinking water so that disease rates could be compared with the SODIS arm |
Who may qualify
- Ages
- 12 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Presence of one or more children aged less than 5 years in the household
Key exclusion criteria (1 listed)
- Chlorinated piped water source available in household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SODIS BottleAlso: Unused 2-litre PET bottles (e.g. Coca-Cola, Pepsi)SODIS Bottles used by SODIS group to treat their drinking water | Other | SODIS Bottles given, Usual practices |
Primary outcome
Dysentery disease rate
Time frame: 12 month
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
Incidence of diarrhoea and numbers of diarrhoeal episodes was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks.
1 secondary outcome
Height and weight benefit
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Background: PubMed 20977257Du 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.
- Background: PubMed 20705982Ubomba-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.
- Background: PubMed 11567937Conroy 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.
- Background: PubMed 8973432Conroy 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.
- Derived from this study: PubMed 21936492du 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.
- SODISWATER project websiteLink provided by the sponsor.
- Information site for SODISLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin G McGuigan, PhD principal investigator
RCSI
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SODIS Bottle in people with Dysentery and Diarrhoea, run by Royal College of Surgeons, Ireland at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cambodia, Kenya, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysentery disease rate (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01306383, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011.