DiarrheaSODISWATERNCT01082107
Solar Disinfection of Drinking Water
A study testing Solar disinfection in transparent containers (plastic bottles) in people with Diarrhea and Dysentery (Bloody Diarrhea), run by Council for Scientific and Industrial Research, South Africa at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Dysentery (Bloody Diarrhea)
- What is being tested?
- Solar disinfection in transparent containers (plastic bottles)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2006to Aug 2009
- 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 Up 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
None listed.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Council for Scientific and Industrial Research (CSIR)
Pretoria, Gauteng, 0001
About this study
Official title: Solar Disinfection of Drinking Water for Use in Developing Countries or in Emergency Situations
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.
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 four African countries
- 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.
- Assessment of gender specific issues.
- Demonstration of the degree of acceptance/ compliance of SODIS as a disinfection method.
- Conditions
- Diarrhea, Dysentery (Bloody Diarrhea)
- Being tested
- Solar disinfection in transparent containers (plastic bottles)
- Medical subject headings
- Diarrhea, Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solar disinfection in transparent containers (plastic bottles)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Solar disinfection of drinking water | Other | Not described Receives: Other: Solar disinfection in transparent containers (plastic bottles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old
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.
Measured: Duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startOct 2006
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Council for Scientific and Industrial Research, South Africa
- Sponsor type
- Other government
- Collaborators
- Royal College of Surgeons, Ireland, European Union
- Investigators
- Kevin G McGuigan, PhD, Principal investigator, Royal College of Surgeons, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082107
- Sponsor's protocol ID
- EU 031650
- Acronym
- SODISWATER
- Status last verified
- Jun 2009
- First submitted
- 5 Mar 2010
- Last updated
- 8 Mar 2010
- Results posted
- No
Publications
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. doi: 10.1016/S0140-6736(96)02309-4.
PubMed 8973432Conroy RM, Meegan ME, Joyce T, McGuigan K, Barnes J. Solar disinfection of water reduces diarrhoeal disease: an update. Arch Dis Child. 1999 Oct;81(4):337-8. doi: 10.1136/adc.81.4.337.
PubMed 10490440Conroy 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 11567937Du 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 20977257
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solar Disinfection of Drinking Water for Use in Developing Countries or in Emergency Situations
- ClinicalTrials.gov ID
- NCT01082107
- Acronym / sponsor ID
- SODISWATER / EU 031650
- Conditions
- Diarrhea, Dysentery (Bloody Diarrhea)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Council for Scientific and Industrial Research, South AfricaOther government
- Collaborators
- Royal College of Surgeons, Ireland, European Union
- Study start
- Oct 2006
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Mar 2010 (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 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
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 four African countries
- 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.
- Assessment of gender specific issues.
- Demonstration of the degree of acceptance/ compliance of SODIS as a disinfection method.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solar disinfection of drinking water | Other | Other: Solar disinfection in transparent containers (plastic bottles) |
Who may qualify
- Ages
- Up 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 (0 listed)
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 |
|---|---|---|
| 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. | Other | Solar disinfection of drinking water |
Primary outcome
Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old
Time frame: Duration of the study
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.
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 8 Mar 2010.
- 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.
- Background: PubMed 10490440Conroy RM, Meegan ME, Joyce T, McGuigan K, Barnes J. Solar disinfection of water reduces diarrhoeal disease: an update. Arch Dis Child. 1999 Oct;81(4):337-8. doi: 10.1136/adc.81.4.337.
- 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.
- Derived from this study: 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.
- Click here for more information on SODISWATER, a research project funded by the European Union (EU) under the 6th Framework Programme (FP6)Link 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
Royal College of Surgeons, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solar disinfection in transparent containers (plastic bottles) in people with Diarrhea and Dysentery (Bloody Diarrhea), run by Council for Scientific and Industrial Research, South Africa at 1 site in South Africa.
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 0 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 8 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old (time frame: Duration of the study). 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 NCT01082107, which also lists 4 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 8 Mar 2010.