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
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01626742
First received: June 21, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hospitalized Elderly
Other: Ready to Drink Flavored Beverage
Other: Ready to drink flavored beverage w/ AN 777
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Return to hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 652
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ready to drink flavored beverage Other: Ready to Drink Flavored Beverage
2 servings a day
Experimental: Ready to drink flavored beverage w/ AN 777 Other: Ready to drink flavored beverage w/ AN 777
2 servings a day

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626742

Contacts
Contact: Bobbie Swearengin, RN 614 624 7182 Bobbie.Swearengin@abbott.com

Locations
United States, Florida
River City Clinical Research Recruiting
Jacksonville, Florida, United States, 32207
Principal Investigator: Mat Vasquez, MD         
United States, Michigan
Bronson Healthcare Group Recruiting
Kalamazoo, Michigan, United States, 49007
Principal Investigator: Thomas Blok, MD         
United States, Ohio
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Ian M Baird, MD, FACP         
United States, South Carolina
Palmetto Senior Primary Care Practice Recruiting
Columbia, South Carolina, United States, 29203
Principal Investigator: Victor Hirth, MD         
United States, Texas
Nix Medical Center Recruiting
San Antonio, Texas, United States, 78205
Principal Investigator: Dina Goytia-Leos, MD         
Puerto Rico
Research and Cardiovascular Corp Recruiting
Ponce, Puerto Rico, 00717
Principal Investigator: Jose Vazquez-Tanus, MD, CCRP         
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Anne C Voss, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01626742     History of Changes
Other Study ID Numbers: BL01
Study First Received: June 21, 2012
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 31, 2014