Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01011608
First received: November 10, 2009
Last updated: April 1, 2011
Last verified: November 2010

November 10, 2009
April 1, 2011
November 2009
August 2010   (final data collection date for primary outcome measure)
Blood chemistry [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011608 on ClinicalTrials.gov Archive Site
  • Product intake [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Functionality (pain, mobility, strength) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Surgical site status [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery

The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hip Fracture
  • Other: Medical Food Supplement
    Medical Food Supplement to be given in divided portions in morning, afternoon and evening
  • Other: standard hospital food
    standard hospital diet ad. lib.
  • Experimental: Medical Food Supplement
    Medical food supplement to be given in divided portions in morning, afternoon and evening
    Intervention: Other: Medical Food Supplement
  • Active Comparator: standard hospital food
    standard hospital diet
    Intervention: Other: standard hospital food
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
September 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is > 45 years of age.
  • Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
  • Subject plans to undergo hip fracture surgery.
  • Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
  • Subject has admission total protein ≤ 70 g/L.
  • Subject has screening serum albumin ≤ 38 g/L.

Exclusion Criteria:

  • Subject is known to be allergic or intolerant to any ingredient found in the study product.
  • Subject has pre-planned surgery other than hip fracture surgery during the study period.
  • Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
  • Subject has active malignancy
  • Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  • Subject has diagnosis of IDDM.
  • Subject has uncontrolled NIDDM determined by HbA1c > 8%.
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01011608
BK52
No
Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Anne C Voss, PhD Abbott Nutrition
Abbott Nutrition
November 2010

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