A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients
This study is currently recruiting participants.
Verified June 2012 by Abbott Nutrition
Sponsor:
Abbott Nutrition
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
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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:
- Male or female ≥ 65 and < 95 years of age.
- Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
- Subjective Global Assessment rating of B or C.
- Length of hospital stay anticipated to be > 3 days and < 12 days
- Able to consume foods and beverages orally.
- Functionally ambulatory during the 30 days prior to admission.
- Has not had a hospital admission in the past 30 days.
Exclusion Criteria
- Requires intensive care unit admission.
- Uncontrolled hypertension
- Diagnosis of diabetes
- Current active cancer or recently treated cancer
- Impaired renal function
- Liver failure, acute Hepatitis, or hepatic encephalopathy
- Active tuberculosis.
- HIV
- Disorder of gastrointestinal tract
- Autoimmune disorder
- Severe COPD
- Intubation, and/or tube or parenteral feeding.
- Expected to be transferred for to an advanced care unit within 3 days.
- 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
- Allergy or intolerance to any of the ingredients in the study products.
- Body mass index of ≥ 40 kg/m2.
- Resident in a nursing home or other residential facility.
Contacts and Locations
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 May 16, 2013