MalnutritionNCT00105625
VA Nutrition Study on Immune Function
An observational study of Malnutrition and Infection, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Malnutrition, Infection, Nosocomial Infection
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be in inpatient rehabilitation, be > 55 years old, and must not suffer any of the following: on active antibiotics; chart documented malignancy, immunodeficiency (HIV, steroid treatment, plasma cell dyscrasia), advanced CHF or malabsorption syndromes (inflammatory bowel diseases such as colitis or Crohn's disease, celiac sprue, gastrectomy, bowel resection, irritable bowel syndrome, complicated diverticulitis, internal fistulae) affecting nutritional status; anemia (Hct<25%), renal failure (serum creatinine > 3.0 mg/dl), liver failure (alk phosp >3x norm or bilirubin >10mg/100ml); estimated LOS <3 months; unable to comply with study procedures.
Who cannot join
- known pre-existing infection requiring antibiotic treatment (e.g. TB, osteomyelitis, SBE) chart documented malignancy, immunodeficiency (e.g. HIV infection, steroid treatment, plasma cell dyscrasia), advanced CHF or malabsorption syndromes (inflammatory bowel diseases such as colitis or Crohn's disease, celiac sprue, gastrectomy, bowel (ileal) resection, irritable bowel syndrome, complicated diverticulitis, or internal fistulae) directly affecting nutritional status documented anemia (Hct <25%), renal (serum creatinine >3.0 mg/dl), or liver failure (SGPT or alkaline phosphatase >3 times normal or bilirubin >10mg/100mL).
- estimated admission <3 months or noncompliance with study procedures (unable/unwilling to perform study procedures)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, 73104
About this study
Official title: Immunocompetency and Nutritive Status in Inpatient Gero-Rehabilitation
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.
Read the 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
- Malnutrition, Infection, Nosocomial Infection
- Keywords
- Geriatrics, Nutrition, Immune function, Infection, Rehabilitation, Inpatient
- Medical subject headings
- Malnutrition, Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startMar 2003
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Jonelle E. Wright, PhD MSN BSN, Principal investigator, Oklahoma City VA Medical Center, Oklahoma City, OK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105625
- Sponsor's protocol ID
- NRI 99-340
- Other IDs
- OUHSC GCRC 0024
- Status last verified
- Jun 2008
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunocompetency and Nutritive Status in Inpatient Gero-Rehabilitation
- ClinicalTrials.gov ID
- NCT00105625
- Acronym / sponsor ID
- NRI 99-340
- Conditions
- Malnutrition, Infection, Nosocomial Infection
- Keywords
- Geriatrics, Nutrition, Immune function, Infection, Rehabilitation, Inpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Oklahoma
- Study start
- Mar 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be in inpatient rehabilitation, be > 55 years old, and must not suffer any of the following: on active antibiotics; chart documented malignancy, immunodeficiency (HIV, steroid treatment, plasma cell dyscrasia), advanced CHF or malabsorption syndromes (inflammatory bowel diseases such as colitis or Crohn's disease, celiac sprue, gastrectomy, bowel resection, irritable bowel syndrome, complicated diverticulitis, internal fistulae) affecting nutritional status; anemia (Hct<25%), renal failure (serum creatinine > 3.0 mg/dl), liver failure (alk phosp >3x norm or bilirubin >10mg/100ml); estimated LOS <3 months; unable to comply with study procedures.
Key exclusion criteria (2 listed)
- known pre-existing infection requiring antibiotic treatment (e.g. TB, osteomyelitis, SBE) chart documented malignancy, immunodeficiency (e.g. HIV infection, steroid treatment, plasma cell dyscrasia), advanced CHF or malabsorption syndromes (inflammatory bowel diseases such as colitis or Crohn's disease, celiac sprue, gastrectomy, bowel (ileal) resection, irritable bowel syndrome, complicated diverticulitis, or internal fistulae) directly affecting nutritional status documented anemia (Hct <25%), renal (serum creatinine >3.0 mg/dl), or liver failure (SGPT or alkaline phosphatase >3 times normal or bilirubin >10mg/100mL).
- estimated admission <3 months or noncompliance with study procedures (unable/unwilling to perform study procedures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonelle E. Wright, PhD MSN BSN principal investigator
Oklahoma City VA Medical Center, Oklahoma City, OK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Infection, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.