Nutritional Intervention for Geriatric Hip Fracture Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01088139
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : May 4, 2011
Information provided by:
Kowloon Hospital, Hong Kong

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Dietary Supplement: Protein supplementation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes
Study Start Date : November 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Experimental: Nutritional Supplementation 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)

Primary Outcome Measures :
  1. Nutritional parameters [ Time Frame: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge ]
    Biochemical and anthropometric measurements

Secondary Outcome Measures :
  1. Rehabilitation Outcomes [ Time Frame: Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge ]
    functional, strength and mobility measurements

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088139

Hong Kong
Department of Rehabilitation, Kowloon Hospital
Kowloon, Hong Kong
Sponsors and Collaborators
Kowloon Hospital, Hong Kong
Principal Investigator: Ma Wai Wai MYINT, MBBS Kowloon Hospital, Hong Kong

Responsible Party: Dr MYINT Ma Wai Wai, Associate Consultant, Department of Rehabilitation, Kowloon Hospital Identifier: NCT01088139     History of Changes
Other Study ID Numbers: KC/KE-08-0118/ER3
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: April 2011

Keywords provided by Kowloon Hospital, Hong Kong:
Nutritional support
Rehabilitation outcomes

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