NCT00058942

Brief Summary

This study is being conducted in Sonoma County, California. Gastrointestinal illness and diarrhea are recognized as a significant cause of morbidity and mortality in the elderly. One study showed that 51% of deaths caused by diarrhea over a 9-year period occurred in individuals over the age of 74 years. Although many infectious diseases are more problematic in the elderly because of a decline in immune function and a higher incidence of pre-existing malnutrition and dehydration, it is still not known what the principal modes of transmission are and which infectious agents are responsible. The principal objective of this study is to evaluate the ability of in-home treatment of tapwater to reduce gastrointestinal illness in non-institutionalized elderly individuals. The trial will test household-level treatment of drinking water by joint use of ultraviolet light and filtration devices. A secondary objective is an estimate of the incidence of specific bacterial, viral, and protozoan agents in stool specimens collected from elderly individuals with gastrointestinal symptoms that might be related to water consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
810

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2000

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

December 11, 2009

Status Verified

November 1, 2006

Enrollment Period

6.8 years

First QC Date

April 15, 2003

Last Update Submit

December 9, 2009

Conditions

Keywords

Drinking Water

Interventions

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • primary source of drinking water used at home is supplied by Sonoma County Water Agency without use of home filtration device or bottled water
  • all individuals living in the home must sign informed consent and agree to have the water treatment device installed
  • no known immunocompromising conditions (including HIV/AIDS, active cancer, or transplant recipients).

You may not qualify if:

  • persons with immunocompromising condition (including HIV/AIDS, active cancer, or transplant recipients)
  • employees and family members of the Sonoma County Water Agency or a Sonoma County Water District

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Berkeley

Berkeley, California, 94720, United States

Location

Related Publications (2)

  • Payment P, Richardson L, Siemiatycki J, Dewar R, Edwardes M, Franco E. A randomized trial to evaluate the risk of gastrointestinal disease due to consumption of drinking water meeting current microbiological standards. Am J Public Health. 1991 Jun;81(6):703-8. doi: 10.2105/ajph.81.6.703.

    PMID: 2029037BACKGROUND
  • Goldstein ST, Juranek DD, Ravenholt O, Hightower AW, Martin DG, Mesnik JL, Griffiths SD, Bryant AJ, Reich RR, Herwaldt BL. Cryptosporidiosis: an outbreak associated with drinking water despite state-of-the-art water treatment. Ann Intern Med. 1996 Mar 1;124(5):459-68. doi: 10.7326/0003-4819-124-5-199603010-00001.

    PMID: 8602703BACKGROUND

MeSH Terms

Conditions

DiarrheaGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System Diseases

Study Officials

  • John M. Colford, M.D., Ph.D.

    School of Public Health, University of California at Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 15, 2003

First Posted

April 16, 2003

Study Start

January 1, 2000

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 11, 2009

Record last verified: 2006-11

Locations