Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 5 of 8 for:    an777

A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Abbott Nutrition.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Abbott Nutrition Identifier:
First received: June 21, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 21, 2012
June 21, 2012
May 2012
April 2014   (final data collection date for primary outcome measure)
Return to hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Return to hospital [ Time Frame: 30 and 60 days ] [ Designated as safety issue: No ]
  • Hospital Days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Activities of Daily Living [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Katz Activities of Daily Living at entry and 90 days
Same as current
Not Provided
Not Provided
A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients
A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

Evaluate effects of an oral nutritional supplement on healthcare outcomes in older hospitalized adults.

Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hospitalized Elderly
  • Other: Ready to Drink Flavored Beverage
    2 servings a day
  • Other: Ready to drink flavored beverage w/ AN 777
    2 servings a day
  • Placebo Comparator: Ready to drink flavored beverage
    Intervention: Other: Ready to Drink Flavored Beverage
  • Experimental: Ready to drink flavored beverage w/ AN 777
    Intervention: Other: Ready to drink flavored beverage w/ AN 777
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female ≥ 65 and < 95 years of age.
  2. Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
  3. Subjective Global Assessment rating of B or C.
  4. Length of hospital stay anticipated to be > 3 days and < 12 days
  5. Able to consume foods and beverages orally.
  6. Functionally ambulatory during the 30 days prior to admission.
  7. Has not had a hospital admission in the past 30 days.

Exclusion Criteria

  1. Requires intensive care unit admission.
  2. Uncontrolled hypertension
  3. Diagnosis of diabetes
  4. Current active cancer or recently treated cancer
  5. Impaired renal function
  6. Liver failure, acute Hepatitis, or hepatic encephalopathy
  7. Active tuberculosis.
  8. HIV
  9. Disorder of gastrointestinal tract
  10. Autoimmune disorder
  11. Severe COPD
  12. Intubation, and/or tube or parenteral feeding.
  13. Expected to be transferred for to an advanced care unit within 3 days.
  14. Severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
  15. Allergy or intolerance to any of the ingredients in the study products.
  16. Body mass index of ≥ 40 kg/m2.
  17. Resident in a nursing home or other residential facility.
65 Years to 95 Years
Contact: Bobbie Swearengin, RN 614 624 7182
United States,   Puerto Rico
Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Anne C Voss, PhD Abbott Nutrition
Abbott Nutrition
June 2012

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