Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000415404
Ethics application status
Approved
Date submitted
19/06/2007
Date registered
17/08/2007
Date last updated
23/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish oil in knee osteoarthritis
Scientific title
A randomized controlled trial in adults with knee osteoarthritis to determine the effect of high dose fish oil compared with low dose fish oil on symptomatic and structural outcomes.
Universal Trial Number (UTN)
Trial acronym
FOSTAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 2183 0
Condition category
Condition code
Musculoskeletal 2278 2278 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Liquid oral high dose fish oil 15ml per day for duration of 2 years.
Intervention code [1] 1840 0
Treatment: Other
Intervention code [2] 1969 0
Treatment: Other
Comparator / control treatment
Liquid oral oil 15ml/day (which contains fish oil 2ml plus 13ml canola oil per day) for duration of 2 years.
Control group
Dose comparison

Outcomes
Primary outcome [1] 3166 0
Change in pain scale of WOMAC index
Timepoint [1] 3166 0
At 3,6,12, 18 and 24 months
Primary outcome [2] 3167 0
Change in knee MRI cartilage volume and defect score
Timepoint [2] 3167 0
At 24 months
Secondary outcome [1] 5282 0
Change in disability scale of WOMAC index
Timepoint [1] 5282 0
At 3,6,12, 18 and 24 months.
Secondary outcome [2] 5283 0
OMERACT-OARSI responder criteria
Timepoint [2] 5283 0
At 3,6,12, 18 and 24 months.
Secondary outcome [3] 5284 0
Analgesic use
Timepoint [3] 5284 0
At 3,6,12, 18 and 24 months
Secondary outcome [4] 5285 0
Change in quality of life using Australian Quality of Life (AQOL) questionnaire
Timepoint [4] 5285 0
At 3,6,12, 18 and 24 months
Secondary outcome [5] 5286 0
Change in MRI scores of synovitis and bone oedema
Timepoint [5] 5286 0
From baseline to 24 months.

Eligibility
Key inclusion criteria
Adults with symptomatic knee osteoarthritis, defined using American College of Rheumatology (ACR) criteria. Symptomatic knee osteoarthritis (score of >4 on at least 1 pain dimension of the Western Ontario and McMaster Osteoarthritis Index (WOMAC).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia or inability to give informed consent; grade 4 (endstage) xray changes in the symptomatic knee; planned knee joint replacement surgery; daily fish oil ingestion >=10mL or 9 standard capsules for the preceding 3 months; contra-indications to MRI.

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)
Central pharmacy allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subject-blinded, clinician-blinded, assessor blinded
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2444 0
Government body
Name [1] 2444 0
National Health and Medical Research Council (NHMRC) Project Grant 451900
Country [1] 2444 0
Australia
Funding source category [2] 2506 0
Government body
Name [2] 2506 0
National Health and Medical Research Council
Country [2] 2506 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
Level 5, 20 Allara Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 2215 0
None
Name [1] 2215 0
N/A
Address [1] 2215 0
Country [1] 2215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4298 0
The Queen Elizabeth Hospital
Ethics committee address [1] 4298 0
Ethics committee country [1] 4298 0
Australia
Date submitted for ethics approval [1] 4298 0
Approval date [1] 4298 0
29/01/2007
Ethics approval number [1] 4298 0
2006170
Ethics committee name [2] 4299 0
Royal Adelaide Hospital
Ethics committee address [2] 4299 0
Ethics committee country [2] 4299 0
Australia
Date submitted for ethics approval [2] 4299 0
Approval date [2] 4299 0
Ethics approval number [2] 4299 0

Summary
Brief summary
The aim of this study is to assess the efficacy of an anti-inflammatory dose of fish oil in the treatment of knee osteoarthritis, both with regard to symptom control and progression of structural changes. These will be assessed using WOMAC questionnaire, analgesic use and knee magnetic resonance imaging (MRI).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27654 0
Address 27654 0
Country 27654 0
Phone 27654 0
Fax 27654 0
Email 27654 0
Contact person for public queries
Name 11029 0
Ruth Battersby
Address 11029 0
Rheumatology Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country 11029 0
Australia
Phone 11029 0
+61 8 82227367
Fax 11029 0
+61 8 82227156
Email 11029 0
ruth.battersby@health.sa.gov.au
Contact person for scientific queries
Name 1957 0
Dr Catherine Hill
Address 1957 0
Rheumatology Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country 1957 0
Australia
Phone 1957 0
+61 8 82226691
Fax 1957 0
+61 8 82227156
Email 1957 0
Catherine.Hill@nwahs.sa.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseSupplementation with omega-3 fish oil has no effect on bone mineral density in adults with knee osteoarthritis: a 2-year randomized controlled trial.2016https://dx.doi.org/10.1007/s00198-015-3438-x
N.B. These documents automatically identified may not have been verified by the study sponsor.