Nutritional Intervention for Geriatric Hip Fracture Patients

This study has been completed.
Sponsor:
Information provided by:
Kowloon Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01088139
First received: March 16, 2010
Last updated: May 3, 2011
Last verified: April 2011

March 16, 2010
May 3, 2011
November 2008
March 2010   (final data collection date for primary outcome measure)
Nutritional parameters [ Time Frame: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge ] [ Designated as safety issue: No ]
Biochemical and anthropometric measurements
Nutritional parameters [ Time Frame: pre, post, 4 weeks post supplement ] [ Designated as safety issue: No ]
Biochemical and anthropometric measurements
Complete list of historical versions of study NCT01088139 on ClinicalTrials.gov Archive Site
Rehabilitation Outcomes [ Time Frame: Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge ] [ Designated as safety issue: No ]
functional, strength and mobility measurements
Rehabilitation Outcomes [ Time Frame: pre, post and 4 weeks post supplement ] [ Designated as safety issue: No ]
functional, strength and mobility measurements
Not Provided
Not Provided
 
Nutritional Intervention for Geriatric Hip Fracture Patients
A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Hip Fractures
Dietary Supplement: Protein supplementation
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.
Other Names:
  • Ensure (Abbott)
  • Resource Breeze (Nestle Nutrition)
  • Compleat (Nestle Nutrition)
  • Glucerna (Abbott)
  • No Intervention: Control
  • Experimental: Nutritional Supplementation
    Intervention: Dietary Supplement: Protein supplementation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
April 2011
March 2010   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01088139
KC/KE-08-0118/ER3
No
Dr MYINT Ma Wai Wai, Associate Consultant, Department of Rehabilitation, Kowloon Hospital
Kowloon Hospital, Hong Kong
Not Provided
Principal Investigator: Ma Wai Wai MYINT, MBBS Kowloon Hospital, Hong Kong
Kowloon Hospital, Hong Kong
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP