Status:
TERMINATED
Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients
Lead Sponsor:
Abbott Nutrition
Conditions:
Pneumonia
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional sup...
Eligibility Criteria
Inclusion
- ≥ 55 years of age.
- Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
- Anticipated length of hospital stay of at least 3 days.
- Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
- Able to consume foods and beverages orally.
Exclusion
- Unstable heart failure which requires ICU admission.
- Severe respiratory disease requiring long-term, continuous oxygen therapy.
- Diabetes.
- Impaired renal function.
- Impaired liver function.
- Cancer.
- Hospitalized for two or more days in past 4 weeks.
- Requires intubation or tube feeding.
- Expected to be transferred to an advanced care unit.
- Body mass index of ≥ 40 kg/m2.
- Active tuberculosis.
- Ascites or severe edema.
- Acute Hepatitis or HIV.
- Disorder of gastrointestinal tract.
- Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
- Medication/dietary supplements/substances that could modulate metabolism or weight.
- Partial or full artificial lower limb.
- Allergy or intolerance to any of the ingredients in the study products.
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01477723
Start Date
October 1 2011
End Date
November 1 2012
Last Update
February 15 2013
Active Locations (14)
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1
Horizon Research Group Inc
Mobile, Alabama, United States, 36608
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Springfield Clinic
Springfield, Illinois, United States, 62703
4
Central Maine Medical Center
Lewiston, Maine, United States, 04240