Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients
NCT ID: NCT01477723
Last Updated: 2013-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
17 participants
INTERVENTIONAL
2011-10-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Oral Nutrition Supplement
Experimental ONS orally Two 8 fl oz servings/day
Experimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day
No Product
No interventions assigned to this group
Interventions
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Experimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day
Eligibility Criteria
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Inclusion Criteria
2. Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
3. Anticipated length of hospital stay of at least 3 days.
4. Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
5. Able to consume foods and beverages orally.
Exclusion Criteria
2. Severe respiratory disease requiring long-term, continuous oxygen therapy.
3. Diabetes.
4. Impaired renal function.
5. Impaired liver function.
6. Cancer.
7. Hospitalized for two or more days in past 4 weeks.
8. Requires intubation or tube feeding.
9. Expected to be transferred to an advanced care unit.
10. Body mass index of ≥ 40 kg/m2.
11. Active tuberculosis.
12. Ascites or severe edema.
13. Acute Hepatitis or HIV.
14. Disorder of gastrointestinal tract.
15. Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
16. Medication/dietary supplements/substances that could modulate metabolism or weight.
17. Partial or full artificial lower limb.
18. Allergy or intolerance to any of the ingredients in the study products.
19. Procedure using iodine-based contrast media within 7 days prior to hospitalization; or, anticipated to need procedure using iodine-based contrast media within 3 days after hospital admission.
55 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Vikkie Mustad, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Horizon Research Group Inc
Mobile, Alabama, United States
Northwestern University
Chicago, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Central Maine Medical Center
Lewiston, Maine, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas Medical Branch
Galveston, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Salem VA Medical Center
Salem, Virginia, United States
Hospital HIMA San Pablo
Bayamón, Puerto Rico, Puerto Rico
Manati Medical Center
Manatí, Puerto Rico, Puerto Rico
Countries
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Other Identifiers
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BK33
Identifier Type: -
Identifier Source: org_study_id
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