Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105625
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Brief Title:
VA Nutrition Study on Immune Function
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Immunocompetency and Nutritive Status in Inpatient Gero-Rehabilitation
Status:
COMPLETED
Status Verified Date:
2008-06
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:
Hospital-acquired infections can occur five times as frequently in rehabilitation patients than in other hospital admissions We postulate that this high infection rate may be due to nutritional problems frequently experienced in these patients In this study we examine the role of nutrition in inpatient geriatric rehabilitation patients immune function and infection rates
Detailed Description:
Background
Hospital-acquired infections can occur five times as frequently in rehabilitation patients than in other hospital admissions We postulated that this high infection rate may be due to nutritional problems frequently experienced in these patients In this study we examined the role of nutrition in inpatient geriatric rehabilitation patients immune function and infection rates
Objectives
We examined immunologic correlates of nutritional status in elderly veterans hospitalized for extended periods of inpatient rehabilitation We tested the hypotheses that geriatric rehabilitation inpatients who receive standard clinical and dietary care 1 experience deficiencies in nutrients important to immune function while they are hospitalized and 2 those patients deficient in nutrients important for immune function experience higher infection rates
Secondary objectives included 1 identifying nutritional and physiological factors that might lead to immune function deficiencies and infection and 2 developing a clinical assessment model of malnutrition that can be used to assess immune function in geriatric rehabilitation inpatients
Methods
In this descriptive cohort study to test Hypothesis 1 we collected data to describe over time in 100 non-acute elderly patients receiving longer-term inpatient rehabilitation care trends in and relationships among 1 caloric protein and immunologically-relevant micronutrient intake 2 body composition metabolism and biochemical indices of nutritional status 3 humoral and cell mediated immunity and 4 infection To test Hypothesis 2 we collected data to examine differences in infection rates in adequately versus inadequately nourished patients Secondarily our study was conducted to examine the relationship of patients eating their nutritional status and their immune function over time
Status
Project data collection activities have been completed A total sample size of 100 patients completed the study protocol No study-related serious adverse events occurred during study implementation As declared above while data analysis activities have been initiated as planned no study results or findings are ready to report at this time
Hospital-acquired infections can occur five times as frequently in rehabilitation patients than in other hospital admissions We postulated that this high infection rate may be due to nutritional problems frequently experienced in these patients In this study we examined the role of nutrition in inpatient geriatric rehabilitation patients immune function and infection rates
Objectives
We examined immunologic correlates of nutritional status in elderly veterans hospitalized for extended periods of inpatient rehabilitation We tested the hypotheses that geriatric rehabilitation inpatients who receive standard clinical and dietary care 1 experience deficiencies in nutrients important to immune function while they are hospitalized and 2 those patients deficient in nutrients important for immune function experience higher infection rates
Secondary objectives included 1 identifying nutritional and physiological factors that might lead to immune function deficiencies and infection and 2 developing a clinical assessment model of malnutrition that can be used to assess immune function in geriatric rehabilitation inpatients
Methods
In this descriptive cohort study to test Hypothesis 1 we collected data to describe over time in 100 non-acute elderly patients receiving longer-term inpatient rehabilitation care trends in and relationships among 1 caloric protein and immunologically-relevant micronutrient intake 2 body composition metabolism and biochemical indices of nutritional status 3 humoral and cell mediated immunity and 4 infection To test Hypothesis 2 we collected data to examine differences in infection rates in adequately versus inadequately nourished patients Secondarily our study was conducted to examine the relationship of patients eating their nutritional status and their immune function over time
Status
Project data collection activities have been completed A total sample size of 100 patients completed the study protocol No study-related serious adverse events occurred during study implementation As declared above while data analysis activities have been initiated as planned no study results or findings are ready to report at this time
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 |
|---|---|---|---|
| OUHSC GCRC 0024 | None | None | None |