Nutritional Intervention for Geriatric Hip Fracture Patients

NCT ID: NCT01088139

Last Updated: 2011-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Nutritional Supplementation

Group Type EXPERIMENTAL

Protein supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ensure (Abbott) Resource Breeze (Nestle Nutrition) Compleat (Nestle Nutrition) Glucerna (Abbott)

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kowloon Hospital, Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Associate Consultant, Department of Rehabilitation, Kowloon Hospital

Principal Investigators

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Ma Wai Wai MYINT, MBBS

Role: PRINCIPAL_INVESTIGATOR

Kowloon Hospital, Hong Kong

Locations

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Department of Rehabilitation, Kowloon Hospital

Kowloon, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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KC/KE-08-0118/ER3

Identifier Type: -

Identifier Source: org_study_id

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