Trial record 5 of 7 for:    an777

A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients - NOURISH Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01626742
First received: June 21, 2012
Last updated: April 24, 2015
Last verified: April 2015

June 21, 2012
April 24, 2015
May 2012
October 2014   (final data collection date for primary outcome measure)
Return to hospital or death [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Return to hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01626742 on ClinicalTrials.gov Archive Site
  • Return to hospital or death [ 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
  • 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
Not Provided
Not Provided
 
A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients - NOURISH Study
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. Also referred to as the NOURISH Study - Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients.

Not Provided
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
652
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female ≥ 65 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.

Exclusion Criteria:

  1. Uncontrolled hypertension
  2. Diagnosis of diabetes
  3. Current active cancer or recently treated cancer
  4. Impaired renal function
  5. Liver failure, acute Hepatitis, or hepatic encephalopathy
  6. Active tuberculosis.
  7. HIV
  8. Disorder of gastrointestinal tract
  9. Autoimmune disorder
  10. Intubation, and/or tube or parenteral feeding.
  11. 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
  12. Allergy or intolerance to any of the ingredients in the study products.
  13. Body mass index of ≥ 40 kg/m2.
  14. Resident in a nursing home or other residential facility.
  15. Planned surgery during course of the study.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01626742
BL01
Yes
Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Menghua Luo, MD, PhD Abbott Nutrition
Study Chair: Jeffrey Nelson, PhD Abbott Nutrition
Abbott Nutrition
April 2015

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