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


Tracking Information

Start Date  ICMJENovember 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2009)
Blood chemistry [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryNo Changes Posted
Current Secondary Outcome Measures ICMJE 
 (submitted: November 10, 2009)
  • 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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEEffect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
Official Title  ICMJEEffect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJEHip Fracture
Intervention  ICMJE
  • 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.
Study Arms / Comparison Groups
  • Medical Food Supplement: Experimental
    Medical food supplement to be given in divided portions in morning, afternoon and evening
    Intervention: Other: Medical Food Supplement
  • standard hospital food: Active Comparator
    standard hospital diet
    Intervention: Other: standard hospital food

Recruitment Information

Estimated Enrollment  ICMJE116
Estimated Completion DateJune 2011
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%.
GenderBoth
Ages45 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bobbie Swearengin, RN614 624 7182Bobbie.Swearengin@abbott.com
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT01011608
Responsible PartyBobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
Study ID Numbers  ICMJEBK 52
Study Sponsor  ICMJEAbbott Nutrition
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Anne C Voss, PhDAbbott Nutrition
Information Provided ByAbbott Nutrition