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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
History of Changes
  Purpose

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 Intervention
Hip Fractures
 Dietary Supplement: Protein supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kowloon Hospital, Hong Kong:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 126
Study Start Date: November 2008
Study Completion Date: April 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088139

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

No publications provided

Responsible Party: Dr MYINT Ma Wai Wai, Associate Consultant, Department of Rehabilitation, Kowloon Hospital
ClinicalTrials.gov Identifier: NCT01088139     History of Changes
Other Study ID Numbers: KC/KE-08-0118/ER3
Study First Received: March 16, 2010
Last Updated: May 3, 2011
Health Authority: Hong Kong: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013