NCT01306383

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
Last Updated

November 10, 2011

Status Verified

February 1, 2011

Enrollment Period

1.3 years

First QC Date

February 28, 2011

Last Update Submit

November 9, 2011

Conditions

Keywords

SODISwaterborneDiseaseDiarrhoeadysentery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Height and weight benefit

    12 months

Study Arms (2)

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.

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

Other: SODIS Bottle

Interventions

SODIS Bottles used by SODIS group to treat their drinking water

Also known as: Unused 2-litre PET bottles (e.g. Coca-Cola, Pepsi)
SODIS Bottles givenUsual practices

Eligibility Criteria

Age12 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Presence of one or more children aged less than 5 years in the household

You may not qualify if:

  • Chlorinated piped water source available in household

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CIC

Phnom Penh, Phnom Penh, Cambodia

Location

ICROSS

Nairobi, Ngong Hills, POBox 507, Kenya

Location

IWSD

Harare, Mount Pleasant, MO422, Zimbabwe

Location

Related Publications (5)

  • 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.

    PMID: 20977257BACKGROUND
  • Ubomba-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.

    PMID: 20705982BACKGROUND
  • 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. doi: 10.1136/adc.85.4.293.

    PMID: 11567937BACKGROUND
  • 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.

    PMID: 8973432BACKGROUND
  • du 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.

Related Links

MeSH Terms

Conditions

DysenteryDiarrheaDisease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Kevin G McGuigan, PhD

    RCSI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

June 1, 2008

Primary Completion

October 1, 2009

Study Completion

May 1, 2010

Last Updated

November 10, 2011

Record last verified: 2011-02

Locations