Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000099325
Ethics application status
Approved
Date submitted
19/02/2008
Date registered
21/02/2008
Date last updated
4/02/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Fish oil and hip fracture
Scientific title
Effect of n-3 fatty acids on outcomes following hip fracture: a pilot study to investigate proof of concept, feasibility of recruitment and adherence to a 6 week fish oil intervention.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly hip fracture patients with malnutrition 2845 0
Condition category
Condition code
Diet and Nutrition 2921 2921 0 0
Other diet and nutrition disorders
Injuries and Accidents 2977 2977 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 week fish oil intervention (15ml/day liquid fish oil (4.9g EPA) OR
9 fish oil capsules/day (4.8g EPA)
Intervention code [1] 2208 0
Treatment: Other
Intervention code [2] 2573 0
Treatment: Drugs
Comparator / control treatment
No fish oil
Control group
Active

Outcomes
Primary outcome [1] 3799 0
Percent weight change
Timepoint [1] 3799 0
At 6 weeks
Primary outcome [2] 3854 0
Levels of inflammatory markers as follows, measured by blood test:
1 C-reactive protein (CRP)
2 Tumour necrosis factor alpha (TNF-alpha)
3 Interleukin 1 beta (IL-1beta)
4 Interleukin 6 (IL-6)
Timepoint [2] 3854 0
At 6 weeks
Secondary outcome [1] 6410 0
Levels of eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) in erythrocyte membrane, measured by blood test
Timepoint [1] 6410 0
At 6 weeks
Secondary outcome [2] 6489 0
Body composition, assessed by bioelectrical impedance analysis (BIA)
Timepoint [2] 6489 0
At 6 weeks

Eligibility
Key inclusion criteria
60 years or over
Hip fracture sufferers
No cognitive impairment according to the Mini Mental State Examination (MMSE score over 24/30)
At risk of subsequent weight loss according to the Simplified Nutrition Appetite Questionnaire (SNAQ score less than or =14/20)
Elevated CRP (6mg/L or more)
Able to consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to fish
Initiation of anti-inflammatory corticosteroids within the prior two weeks
Ingestion of n-3 fatty acid supplements within four weeks of study initiation
Life expectancy less than 6 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 775 0
5041

Funding & Sponsors
Funding source category [1] 3046 0
University
Name [1] 3046 0
Flinders University
Country [1] 3046 0
Australia
Funding source category [2] 3096 0
Self funded/Unfunded
Name [2] 3096 0
Country [2] 3096 0
Primary sponsor type
University
Name
Dr Michelle Miller
Address
Department of Nutrition & Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 2788 0
University
Name [1] 2788 0
Professor Maria Crotty
Address [1] 2788 0
Department of Rehabilitation and Aged Care
Flinders University
GPO Box 2100
Adelaide SA 5001
Country [1] 2788 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5079 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 5079 0
Repatriation General Hospital
Daws Road
Daw Park
South Australia 5041
Ethics committee country [1] 5079 0
Australia
Date submitted for ethics approval [1] 5079 0
24/10/2007
Approval date [1] 5079 0
06/02/2008
Ethics approval number [1] 5079 0
72/07

Summary
Brief summary
Inflammatory markers have been found to be raised in hip fracture patients. It is plausible that fish oils will counteract production of these chemicals and reduce weight and muscle loss which is experienced in many of these patients. This study will investigate proof of this concept, feasibility of recruitment and adherence to fish oil liquid or capsules.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28130 0
Address 28130 0
Country 28130 0
Phone 28130 0
Fax 28130 0
Email 28130 0
Contact person for public queries
Name 11287 0
Dr Michelle Miller
Address 11287 0
Dept Nutrition & Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 11287 0
Australia
Phone 11287 0
08 8204 5328
Fax 11287 0
08 8204 6406
Email 11287 0
[email protected]
Contact person for scientific queries
Name 2215 0
Dr Michelle Miller
Address 2215 0
Dept Nutrition & Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 2215 0
Australia
Phone 2215 0
08 8204 5328
Fax 2215 0
08 8204 6406
Email 2215 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.