Nutritional Intervention for Geriatric Hip Fracture Patients
Primary Purpose
Hip Fractures
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Protein supplementation
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Fractures focused on measuring Nutritional support, Rehabilitation outcomes
Eligibility Criteria
Inclusion Criteria:
- Age 60 years or older
- Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment
Exclusion Criteria:
- Patients who require tube feeding
- Patients in unstable medical condition
- Body mass index (BMI) ≧ 25
- Malignancy
- Conditions with contraindication for high protein diet
- Mentally incapacitated and inability to communicate or understand the consent.
Sites / Locations
- Department of Rehabilitation, Kowloon Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Nutritional Supplementation
Arm Description
Outcomes
Primary Outcome Measures
Nutritional parameters
Biochemical and anthropometric measurements
Secondary Outcome Measures
Rehabilitation Outcomes
functional, strength and mobility measurements
Full Information
NCT ID
NCT01088139
First Posted
March 16, 2010
Last Updated
May 3, 2011
Sponsor
Kowloon Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01088139
Brief Title
Nutritional Intervention for Geriatric Hip Fracture Patients
Official Title
A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kowloon Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized controlled, observer blinded trial to study the beneficial effect of nutritional supplementation in elderly Hong Kong patients after hip fracture surgery during rehabilitation and at 4 weeks follow up. The control group will receive Calcium and Vitamin D supplementation whereas the intervention group will receive a moderately high dose protein nutritional supplementation in addition to Vitamin D and Calcium. Both groups undergo the same rehabilitation program and dietary counseling before discharge. They are followed up 4 weeks after discharge or completion of supplementation. The outcome parameters are nutritional parameters and rehabilitation outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Nutritional support, Rehabilitation outcomes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Nutritional Supplementation
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplementation
Other Intervention Name(s)
Ensure (Abbott), Resource Breeze (Nestle Nutrition), Compleat (Nestle Nutrition), Glucerna (Abbott)
Intervention Description
Ready made protein supplement drinks with approximate protein content of 18-24g per 500ml per day. Caloric content is 490 to 530Kcal depending on the brand of drink.
Primary Outcome Measure Information:
Title
Nutritional parameters
Description
Biochemical and anthropometric measurements
Time Frame
Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge
Secondary Outcome Measure Information:
Title
Rehabilitation Outcomes
Description
functional, strength and mobility measurements
Time Frame
Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 60 years or older
Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment
Exclusion Criteria:
Patients who require tube feeding
Patients in unstable medical condition
Body mass index (BMI) ≧ 25
Malignancy
Conditions with contraindication for high protein diet
Mentally incapacitated and inability to communicate or understand the consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma Wai Wai MYINT, MBBS
Organizational Affiliation
Kowloon Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Kowloon Hospital
City
Kowloon
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Nutritional Intervention for Geriatric Hip Fracture Patients
We'll reach out to this number within 24 hrs