A Trial of Tap Water Treatment in the Elderly - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00058942

Purpose

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.

Condition	Intervention
Diarrhea Gastrointestinal Diseases	Device: home drinking water treatment device

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomized Trial of Tap Water Treatment in the Elderly

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Drinking Water

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:	810
Study Start Date:	January 2000
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

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Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

55 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).

Exclusion criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058942

Locations

United States, California
University of California Berkeley
Berkeley, California, United States, 94720

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

John M. Colford, M.D., Ph.D.

School of Public Health, University of California at Berkeley

More Information

Publications:

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.

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.

Study ID Numbers:	AG0002, 5R01AG016634-03
Study First Received:	April 15, 2003
Last Updated:	December 9, 2009
ClinicalTrials.gov Identifier:	NCT00058942 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Drinking Water

Additional relevant MeSH terms:

Signs and Symptoms
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010