Trials / Completed
CompletedNCT00105625
VA Nutrition Study on Immune Function
Immunocompetency and Nutritive Status in Inpatient Gero-Rehabilitation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- US Department of Veterans Affairs · Federal
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2003-03-01
- Primary completion
- 2007-09-01
- Completion
- 2007-09-01
- First posted
- 2005-03-17
- Last updated
- 2015-04-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00105625. Inclusion in this directory is not an endorsement.