Nutritional Intervention for Geriatric Hip Fracture Patients

Hip Fractures Clinical Trial

Official title:

A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088139
• Other study ID #: KC/KE-08-0118/ER3
• Status: Completed
• Phase: N/A
• First received: March 16, 2010
• Last updated: May 3, 2011
• Start date: November 2008
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Kowloon Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Rehabilitation, Kowloon Hospital	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Kowloon Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional parameters	Biochemical and anthropometric measurements	Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge
Secondary	Rehabilitation Outcomes	functional, strength and mobility measurements	Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge