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Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01477723
First received: November 19, 2011
Last updated: February 14, 2013
Last verified: February 2013

November 19, 2011
February 14, 2013
October 2011
November 2012   (final data collection date for primary outcome measure)
Leg Lean Mass [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01477723 on ClinicalTrials.gov Archive Site
  • Body Weight [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]
  • Activities of daily living [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients
Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

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 supplement; to collect post-discharge information.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pneumonia
Other: Experimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day
  • Experimental: Experimental Oral Nutrition Supplement
    Experimental ONS orally Two 8 fl oz servings/day
    Intervention: Other: Experimental Oral Nutritional Supplement
  • No Intervention: No Product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. ≥ 55 years of age.
  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:

  1. Unstable heart failure which requires ICU admission.
  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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01477723
BK33
Yes
Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Vikkie Mustad, PhD Abbott Nutrition
Abbott Nutrition
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP