Nutritional Intervention for Geriatric Hip Fracture Patients
This study has been completed.
Sponsor:
Kowloon Hospital, Hong Kong
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
| Tracking Information | |||||
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| First Received Date ICMJE | March 16, 2010 | ||||
| Last Updated Date | May 3, 2011 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
Nutritional parameters [ Time Frame: pre, post, 4 weeks post supplement ] [ Designated as safety issue: No ] Biochemical and anthropometric measurements |
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| Change History | Complete list of historical versions of study NCT01088139 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE |
Rehabilitation Outcomes [ Time Frame: pre, post and 4 weeks post supplement ] [ Designated as safety issue: No ] functional, strength and mobility measurements |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nutritional Intervention for Geriatric Hip Fracture Patients | ||||
| Official Title ICMJE | A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Hip Fractures | ||||
| Intervention ICMJE | 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:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 126 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01088139 | ||||
| Other Study ID Numbers ICMJE | KC/KE-08-0118/ER3 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr MYINT Ma Wai Wai, Associate Consultant, Department of Rehabilitation, Kowloon Hospital | ||||
| Study Sponsor ICMJE | Kowloon Hospital, Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Kowloon Hospital, Hong Kong | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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