Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients
This study has been terminated.
(Low enrollment)
Sponsor:
Abbott Nutrition
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia |
Other: Experimental Oral Nutritional Supplement |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation 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:
- Leg Lean Mass [ Time Frame: baseline to day 30 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 17 |
| Study Start Date: | October 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental Oral Nutrition Supplement
Experimental ONS orally Two 8 fl oz servings/day
|
Other: Experimental Oral Nutritional Supplement
Experimental ONS orally Two 8 fl oz servings/day
|
| No Intervention: No Product |
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ≥ 55 years of age.
- Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
- Anticipated length of hospital stay of at least 3 days.
- Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
- Able to consume foods and beverages orally.
Exclusion Criteria:
- Unstable heart failure which requires ICU admission.
- Severe respiratory disease requiring long-term, continuous oxygen therapy.
- Diabetes.
- Impaired renal function.
- Impaired liver function.
- Cancer.
- Hospitalized for two or more days in past 4 weeks.
- Requires intubation or tube feeding.
- Expected to be transferred to an advanced care unit.
- Body mass index of ≥ 40 kg/m2.
- Active tuberculosis.
- Ascites or severe edema.
- Acute Hepatitis or HIV.
- Disorder of gastrointestinal tract.
- Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
- Medication/dietary supplements/substances that could modulate metabolism or weight.
- Partial or full artificial lower limb.
- Allergy or intolerance to any of the ingredients in the study products.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477723
Locations
| United States, Alabama | |
| Horizon Research Group Inc | |
| Mobile, Alabama, United States, 36608 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Springfield Clinic | |
| Springfield, Illinois, United States, 62703 | |
| United States, Maine | |
| Central Maine Medical Center | |
| Lewiston, Maine, United States, 04240 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| United States, South Carolina | |
| Medical University of South Carolina (MUSC) | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| The University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-1144 | |
| United States, Virginia | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| Salem VA Medical Center | |
| Salem, Virginia, United States, 24153 | |
| Puerto Rico | |
| Hospital HIMA San Pablo | |
| Bayamon, Puerto Rico, 00959 | |
| Manati Medical Center | |
| Manati, Puerto Rico, 00647 | |
Sponsors and Collaborators
Abbott Nutrition
Investigators
| Study Chair: | Vikkie Mustad, PhD | Abbott Nutrition |
More Information
No publications provided
| Responsible Party: | Abbott Nutrition |
| ClinicalTrials.gov Identifier: | NCT01477723 History of Changes |
| Other Study ID Numbers: | BK33 |
| Study First Received: | November 19, 2011 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on June 17, 2013