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
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 16, 2010
CompletedFirst Posted
Study publicly available on registry
March 17, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 4, 2011
April 1, 2011
1.3 years
March 16, 2010
May 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nutritional parameters
Biochemical and anthropometric measurements
Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge
Secondary Outcomes (1)
Rehabilitation Outcomes
Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge
Study Arms (2)
Control
NO INTERVENTIONNutritional Supplementation
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Age 60 years or older
- Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Rehabilitation, Kowloon Hospital
Kowloon, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ma Wai Wai MYINT, MBBS
Kowloon Hospital, Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 16, 2010
First Posted
March 17, 2010
Study Start
November 1, 2008
Primary Completion
March 1, 2010
Study Completion
April 1, 2011
Last Updated
May 4, 2011
Record last verified: 2011-04