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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Femoral Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014