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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01088139
Other study ID # KC/KE-08-0118/ER3
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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