Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058942
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2003-04-15
Brief Title:
A Trial of Tap Water Treatment in the Elderly
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Randomized Trial of Tap Water Treatment in the Elderly
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
There is heated debate in the United States about the extent to which waterborne infectious diseases may be transmitted to human beings through drinking water that meets federal standards for pathogen removal This debate is even more pronounced among elderly immunocompromised persons and their health care providers because of the prolonged illness syndromes generally gastrointestinal and even death that may occur in these persons after the ingestion of infectious agents Concerns about drinking water have been heightened by the findings of Payment et al in Canada which suggested that approximately 25 of highly credible gastrointestinal illness in a community might be due to drinking water
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 Lew et al 1991 In a review of sensitive populations Gerba et al 1996 reported case fatality rates for specific enteric pathogens 10 to 100 times higher in this group compared to the general population 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
Furthermore studies on gastrointestinal illness in the elderly are important now because of an expanding elderly population and the heightened interest in the development of vaccine strategies These developments necessitate a clearer understanding of the relative contribution of various pathogens to gastrointestinal illness in this population Although many agents responsible for gastrointestinal illness have previously been difficult to identify reliably state-of-the-art laboratory technology including molecular methods now make such study more feasible We will use laboratory techniques to identify the specific causal agents of gastrointestinal illness in the intervention and placebo groups and to estimate the relative prevalence of these pathogens as a cause of gastrointestinal illness
This study is a randomized triple-blinded placebo-controlled intervention trial in an elderly population ie over 55 years of age The intervention to be tested is household-level treatment of drinking water by joint use of ultraviolet light and filtration devices in the form of a point-of-use countertop unit The project site is the city of Sonoma California and adjacent regions of southern Sonoma County also served by the Sonoma County Water Agency that receive their drinking water from ground water aquifers under the Russian River The unit of randomization and intervention will be individual households The unit of analysis will be the individual participants within households adjusted for intra-household clustering ie the within-household correlation The participants the study investigators and the data analysts will be blinded to the assignment of individual households to active or placebo device except for one study staff member who will keep the randomization codes This un-blinded staff member will not have contact with any of the study participants nor will heshe have access to any data on the study participants during the course of the study
The primary objective is to determine the incidence of gastrointestinal disease in a group of households using a home drinking water device combined filtrationUV light and in a group of households receiving a placebo device that is inactive but identical in appearance This information will be used to estimate the burden of gastrointestinal illness in an elderly population due to the consumption at home of drinking water that meets regulatory standards but receives no additional treatment
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 and that might be related to water consumption To determine the rates of asymptomatic infections we will also test stool specimens from individuals who are not sick Further questions about seroprevalence of these waterborne pathogens and the immune response they elicit will be answered by testing serum samples taken from all participants at critical junctures during the study
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 Lew et al 1991 In a review of sensitive populations Gerba et al 1996 reported case fatality rates for specific enteric pathogens 10 to 100 times higher in this group compared to the general population 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
Furthermore studies on gastrointestinal illness in the elderly are important now because of an expanding elderly population and the heightened interest in the development of vaccine strategies These developments necessitate a clearer understanding of the relative contribution of various pathogens to gastrointestinal illness in this population Although many agents responsible for gastrointestinal illness have previously been difficult to identify reliably state-of-the-art laboratory technology including molecular methods now make such study more feasible We will use laboratory techniques to identify the specific causal agents of gastrointestinal illness in the intervention and placebo groups and to estimate the relative prevalence of these pathogens as a cause of gastrointestinal illness
This study is a randomized triple-blinded placebo-controlled intervention trial in an elderly population ie over 55 years of age The intervention to be tested is household-level treatment of drinking water by joint use of ultraviolet light and filtration devices in the form of a point-of-use countertop unit The project site is the city of Sonoma California and adjacent regions of southern Sonoma County also served by the Sonoma County Water Agency that receive their drinking water from ground water aquifers under the Russian River The unit of randomization and intervention will be individual households The unit of analysis will be the individual participants within households adjusted for intra-household clustering ie the within-household correlation The participants the study investigators and the data analysts will be blinded to the assignment of individual households to active or placebo device except for one study staff member who will keep the randomization codes This un-blinded staff member will not have contact with any of the study participants nor will heshe have access to any data on the study participants during the course of the study
The primary objective is to determine the incidence of gastrointestinal disease in a group of households using a home drinking water device combined filtrationUV light and in a group of households receiving a placebo device that is inactive but identical in appearance This information will be used to estimate the burden of gastrointestinal illness in an elderly population due to the consumption at home of drinking water that meets regulatory standards but receives no additional treatment
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 and that might be related to water consumption To determine the rates of asymptomatic infections we will also test stool specimens from individuals who are not sick Further questions about seroprevalence of these waterborne pathogens and the immune response they elicit will be answered by testing serum samples taken from all participants at critical junctures during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG016634-03 | NIH | None | httpsreporternihgovquickSearch5R01AG016634-03 |