ANZCTR - Registration

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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

Condition category

Condition code

Musculoskeletal

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]

Treatment: Other

Intervention code [2]

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]

Change in pain scale of WOMAC index

Timepoint [1]

At 3,6,12, 18 and 24 months

Primary outcome [2]

Change in knee MRI cartilage volume and defect score

Timepoint [2]

At 24 months

Secondary outcome [1]

Change in disability scale of WOMAC index

Timepoint [1]

At 3,6,12, 18 and 24 months.

Secondary outcome [2]

OMERACT-OARSI responder criteria

Timepoint [2]

At 3,6,12, 18 and 24 months.

Secondary outcome [3]

Analgesic use

Timepoint [3]

At 3,6,12, 18 and 24 months

Secondary outcome [4]

Change in quality of life using Australian Quality of Life (AQOL) questionnaire

Timepoint [4]

At 3,6,12, 18 and 24 months

Secondary outcome [5]

Change in MRI scores of synovitis and bone oedema

Timepoint [5]

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?

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]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) Project Grant 451900

Address [1]

Canberra

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council

Address [2]

Level 5, 20 Allara Street
Canberra ACT 2601

Country [2]

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]

None

Name [1]

N/A

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Queen Elizabeth Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/01/2007

Ethics approval number [1]

2006170

Ethics committee name [2]

Royal Adelaide Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ruth Battersby

Address

Rheumatology Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011

Country

Australia

Phone

+61 8 82227367

Fax

+61 8 82227156

[email protected]

Contact person for scientific queries

Name

Dr Catherine Hill

Address

Rheumatology Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011

Country

Australia

Phone

+61 8 82226691

Fax

+61 8 82227156

[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

Source	Title	Year of Publication	DOI
Embase	Supplementation with omega-3 fish oil has no effect on bone mineral density in adults with knee osteoarthritis: a 2-year randomized controlled trial.	2016	https://dx.doi.org/10.1007/s00198-015-3438-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically