Hip FracturesNCT01088139
Nutritional Intervention for Geriatric Hip Fracture Patients
A study testing Protein supplementation in people with Hip Fractures, run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Protein supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older
- Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes
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.
- Conditions
- Hip Fractures
- Being tested
- Protein supplementation
- Keywords
- Nutritional support, Rehabilitation outcomes
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary supplement
Also called Ensure (Abbott), Resource Breeze (Nestle Nutrition), Compleat (Nestle Nutrition), Glucerna (Abbott)
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Nutritional Supplementation | Experimental | Not described Receives: Dietary Supplement: Protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional parameters
Biochemical and anthropometric measurements
Measured: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge
Secondary outcomes (1)
Rehabilitation Outcomes
functional, strength and mobility measurements
Measured: Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowloon Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Ma Wai Wai MYINT, MBBS, Principal investigator, Kowloon Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088139
- Sponsor's protocol ID
- KC/KE-08-0118/ER3
- Status last verified
- Apr 2011
- First submitted
- 16 Mar 2010
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT01088139
- Acronym / sponsor ID
- KC/KE-08-0118/ER3
- Conditions
- Hip Fractures
- Keywords
- Nutritional support, Rehabilitation outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Kowloon Hospital, Hong KongUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Nutritional Supplementation | Experimental | Dietary Supplement: Protein supplementation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 60 years or older
- Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment
Key exclusion criteria (6 listed)
- Patients who require tube feeding
- Patients in unstable medical condition
- Body mass index (BMI) ≧ 25
- Malignancy
- Conditions with contraindication for high protein diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplementationAlso: Ensure (Abbott), Resource Breeze (Nestle Nutrition), Compleat (Nestle Nutrition), Glucerna (Abbott)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. | Dietary supplement | Nutritional Supplementation |
Primary outcome
Nutritional parameters
Time frame: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge
Biochemical and anthropometric measurements
1 secondary outcome
Rehabilitation Outcomes
Time frame: Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ma Wai Wai MYINT, MBBS principal investigator
Kowloon Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation in people with Hip Fractures, run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional parameters (time frame: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2011.