Back to resultsEffect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
Primary Purpose
Hip Fracture
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Medical Food Supplement
standard hospital food
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture
Eligibility 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%.
Sites / Locations
- Ural State Medical Academy
- Regional Clinical Hospital #1
- City Clinical Hospital #15
- City Clinical Hospital #12
- City Clinical Hospital #31
- City Clinical Hospital n.a. Botkina
- State Novosibirsk Regional Hospital
- Alexandrovskaya City Hospital
- Saint Petersburg State Medical Academy Mechnikova
- Samara Regional Clinical Hospital
- Ufa Medical University, Hospital of Emergency Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medical Food Supplement
standard hospital food
Arm Description
Medical food supplement to be given in divided portions in morning, afternoon and evening
standard hospital diet
Outcomes
Primary Outcome Measures
Blood chemistry
Secondary Outcome Measures
Product intake
Functionality (pain, mobility, strength)
Surgical site status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01011608
Brief Title
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
Official Title
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Food Supplement
Arm Type
Experimental
Arm Description
Medical food supplement to be given in divided portions in morning, afternoon and evening
Arm Title
standard hospital food
Arm Type
Active Comparator
Arm Description
standard hospital diet
Intervention Type
Other
Intervention Name(s)
Medical Food Supplement
Intervention Description
Medical Food Supplement to be given in divided portions in morning, afternoon and evening
Intervention Type
Other
Intervention Name(s)
standard hospital food
Intervention Description
standard hospital diet ad. lib.
Primary Outcome Measure Information:
Title
Blood chemistry
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Product intake
Time Frame
28 days
Title
Functionality (pain, mobility, strength)
Time Frame
28 days
Title
Surgical site status
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne C Voss, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Ural State Medical Academy
City
Ekaterinburg
ZIP/Postal Code
620007
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
City Clinical Hospital #15
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
City Clinical Hospital #12
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
City Clinical Hospital #31
City
Moscow
ZIP/Postal Code
119415
Country
Russian Federation
Facility Name
City Clinical Hospital n.a. Botkina
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
State Novosibirsk Regional Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Alexandrovskaya City Hospital
City
Saint Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Saint Petersburg State Medical Academy Mechnikova
City
Saint Petersburg
Country
Russian Federation
Facility Name
Samara Regional Clinical Hospital
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Ufa Medical University, Hospital of Emergency Care
City
Ufa
ZIP/Postal Code
450092
Country
Russian Federation
12. IPD Sharing Statement
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Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
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