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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hip Fracture
 Other: Medical Food Supplement
Other: standard hospital food
 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: Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Blood chemistry [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 127
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medical Food Supplement
Medical food supplement to be given in divided portions in morning, afternoon and evening
 Other: Medical Food Supplement
Medical Food Supplement to be given in divided portions in morning, afternoon and evening
Active Comparator: standard hospital food
standard hospital diet
 Other: standard hospital food
standard hospital diet ad. lib.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011608

Locations
Russian Federation
Ural State Medical Academy
Ekaterinburg, Russian Federation, 620007
Regional Clinical Hospital #1
Krasnodar, Russian Federation, 350086
City Clinical Hospital n.a. Botkina
Moscow, Russian Federation, 125284
City Clinical Hospital #12
Moscow, Russian Federation, 115516
City Clinical Hospital #15
Moscow, Russian Federation, 111539
City Clinical Hospital #31
Moscow, Russian Federation, 119415
State Novosibirsk Regional Hospital
Novosibirsk, Russian Federation, 630087
Saint Petersburg State Medical Academy Mechnikova
Saint Petersburg, Russian Federation
Alexandrovskaya City Hospital
Saint Petersburg, Russian Federation, 193312
Samara Regional Clinical Hospital
Samara, Russian Federation, 443095
Ufa Medical University, Hospital of Emergency Care
Ufa, Russian Federation, 450092
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Anne C Voss, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01011608     History of Changes
Other Study ID Numbers: BK52
Study First Received: November 10, 2009
Last Updated: April 1, 2011
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 16, 2013