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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Other: Medical Food Supplement; Other: standard hospital food

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation, 620007
    • Ural State Medical Academy
  • Krasnodar, Russian Federation, 350086
    • Regional Clinical Hospital #1
  • Moscow, Russian Federation, 111539
    • City clinical hospital #15
  • Moscow, Russian Federation, 115516
    • City Clinical Hospital #12
  • Moscow, Russian Federation, 119415
    • City Clinical Hospital #31
  • Moscow, Russian Federation, 125284
    • City Clinical Hospital n.a. Botkina
  • Novosibirsk, Russian Federation, 630087
    • State Novosibirsk Regional Hospital
  • Saint Petersburg, Russian Federation, 193312
    • Alexandrovskaya City Hospital
  • Saint Petersburg, Russian Federation
    • Saint Petersburg State Medical Academy Mechnikova
  • Samara, Russian Federation, 443095
    • Samara Regional Clinical Hospital
  • Ufa, Russian Federation, 450092
    • Ufa Medical University, Hospital of Emergency Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood chemistry	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Product intake	28 days
Functionality (pain, mobility, strength)	28 days
Surgical site status	28 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Anne C Voss, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Estimate): April 4, 2011
• Last Update Submitted That Met QC Criteria: April 1, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: BK52