NCT00731497

Brief Summary

The importance of waterborne gastrointestinal illness throughout the developing world, the existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under actual field conditions, and the experience of our tri-national collaborative research team in successfully conducting large scale drinking water intervention and observational studies in both the United States and the developing world encourage us to propose the following randomized controlled trial in which our specific aims are to:

  • Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in 660 children under the age of five years in rural Bolivia that are randomly selected from 22 villages ;
  • Define, through an extensive microbiologic testing component, the baseline rates of pathogen-specific diarrheal illnesses and the pathogens responsible for the differences in diarrheal illness between active and control groups;
  • Document the actual use and acceptance of SODIS by participants in the study;
  • Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at household level;
  • Examine through mathematical disease modelling the effects of the presence of multiple transmission pathways within a village on the preventable fraction estimate due to the introduction of SODIS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,163

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

2 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

September 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

August 7, 2008

Last Update Submit

December 15, 2017

Conditions

Diarrhea

Keywords

SODISDrinking WaterDisinfectionIntervention Trial

Outcome Measures

Primary Outcomes (1)

  • Incidence of diarrhea

    weekly

Secondary Outcomes (2)

  • analysis of stool

    baseline and at diarreal episodes

  • water quality

    systematically

Study Arms (2)

1

ACTIVE COMPARATOR

children in households/villages using Solar Water Disinfection (SODIS) method of disinfecting household drinking water

Device: Solar Water Disinfection (SODIS)

2

NO INTERVENTION

children in households/villages where Solar Water Disinfection (SODIS) has not been implemented

Interventions

Solar Water Disinfection (SODIS)DEVICE

Intervention group has SODIS implemented at the household level as a way to disinfect drinking water

Also known as: SODIS
1

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Consent of Community Leadership
  • Permanent residence in village
  • Consent of both parents and all other adult household members
  • Age 6 months to 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de San Simon

Cochabamba, Bolivia

Location

Water and Stool Lab

Totora, Bolivia

Location

Related Publications (2)

  • Christen A, Duran Pacheco G, Hattendorf J, Arnold BF, Cevallos M, Indergand S, Colford JM, Mausezahl D. Factors associated with compliance among users of solar water disinfection in rural Bolivia. BMC Public Health. 2011 Apr 4;11:210. doi: 10.1186/1471-2458-11-210.

    PMID: 21463508DERIVED

  • Mausezahl D, Christen A, Pacheco GD, Tellez FA, Iriarte M, Zapata ME, Cevallos M, Hattendorf J, Cattaneo MD, Arnold B, Smith TA, Colford JM Jr. Solar drinking water disinfection (SODIS) to reduce childhood diarrhoea in rural Bolivia: a cluster-randomized, controlled trial. PLoS Med. 2009 Aug;6(8):e1000125. doi: 10.1371/journal.pmed.1000125. Epub 2009 Aug 18.

    PMID: 19688036DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John M Colford, M.D., Ph.D.

    U.C. Berkeley

    PRINCIPAL INVESTIGATOR

  • Daniel Mausezahl, Ph.D.

    Swiss Tropical & Public Health Institute

    PRINCIPAL INVESTIGATOR

  • Andri Christen

    Bolivia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 11, 2008

Study Start

September 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

BO(2)