Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000207617
Ethics application status
Approved
Date submitted
17/08/2005
Date registered
25/08/2005
Date last updated
24/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish Oils (Omega 3) in ischaemic stroke
Scientific title
A Randomised, Placebo-Controlled Intervention Trial of Omega-3 PUFA, (Fish Oils), in People with Ischaemic Stroke
Secondary ID [1] 273457 0
HRC
Universal Trial Number (UTN)
Trial acronym
FOILS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Cerebrovascular Disease 288 0
Ischaemic Cerebrovascular Stroke 289 0
Condition category
Condition code
Stroke 325 325 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive 3 gm of fish oil (containing omega-3 PUFAs) orally for the treatment group Participants are seen at 0 and 12 weeks for clinical assessments, anthropometry, venepuncture for haematological and biochemical analyses, assessment of compliance and the recording of adverse events. In addition, a telephone follow-up visit will be performed at 6 and 11 weeks to ascertain safety data (SAEs) and compliance to study treatment.
Intervention code [1] 203 0
None
Comparator / control treatment
Placebo (palm and soy oil) for the control group for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 380 0
To evaluate the effectiveness of Omega-3 PUFAs in improving lipid profiles
Timepoint [1] 380 0
At 12 weeks
Secondary outcome [1] 844 0
To evaluate the treatment on changes in weight, blood pressure, inflammatory and haemostatic markers of cardiovascular disease, and mood.
Timepoint [1] 844 0
The study will provide efficacy and tolerability data on the study treatment given for a total of 12 weeks.
Secondary outcome [2] 845 0
Lipid profile (TC, LDL-C, HDL-C, TG [primary]; LDL-particle size, Apo B), inflammatory markers (hsC-RP, LFT, FBC, ESR, ferritin), haemostatic clotting (fibrinogen), blood pressure, body mass index (BMI), body weight, waist to hip ratio, mood (GHQ 28-item general health questionnaire) and health-related quality of life (SF-36 item short form questionnaire).
Timepoint [2] 845 0
Will be collected at baseline and 12 weeks.

Eligibility
Key inclusion criteria
1. CT confirmed first-ever or recurrent ischaemic stroke 2. Clinically stable with atheromatous disease history greater than 3 months.
Minimum age
45 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known intolerance or hypersensitivity to fish and /or fish oils. 2. Current use of fish oils (dietary supplements) 3. Known to be pregnant or breast feeding 4. Active disease causing malabsorption.

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)
Identical opaque gelatin capsules will be assigned and presented in identical foil blister packs in sealed numbered envelopes. Sealed master envelopes have been prepared by the blister pack manufacturer and sent directly to the Data and Safety Monitoring Board and to the Chief Executive Officer of FPA Health. The treatment codes will only be broken following completion of the analysis of the primary end point. Therefore, allocation concealment will be maintained until the end of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment outside Australia
Country [1] 137 0
New Zealand
State/province [1] 137 0

Funding & Sponsors
Funding source category [1] 384 0
Government body
Name [1] 384 0
Health Research Council
Country [1] 384 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council (New Zealand)
Address
Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
Country
New Zealand
Secondary sponsor category [1] 313 0
University
Name [1] 313 0
CTRU, The University of Auckland
Address [1] 313 0
Level 4, School of Population Health, Tamaki Campus, University of Auckland, Glen Innes, Auckland 1072
Country [1] 313 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1377 0
Auckland
Ethics committee address [1] 1377 0
Ethics committee country [1] 1377 0
New Zealand
Date submitted for ethics approval [1] 1377 0
Approval date [1] 1377 0
Ethics approval number [1] 1377 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35924 0
Address 35924 0
Country 35924 0
Phone 35924 0
Fax 35924 0
Email 35924 0
Contact person for public queries
Name 9392 0
Dr Colin Howe
Address 9392 0
Clinical Trials Reseach Unit
University of Auckland
Private Bag 92019
Glen Innes Auckland 1
Country 9392 0
New Zealand
Phone 9392 0
+64 9 3737999
Fax 9392 0
+64 9 3731710
Email 9392 0
c.howe@ctru.auckland.ac.nz
Contact person for scientific queries
Name 320 0
Dr Colin Howe
Address 320 0
Clinical Trials Reseach Unit
University of Auckland
Private Bag 92019
Glen Innes Auckland 1
Country 320 0
New Zealand
Phone 320 0
+64 9 3737999
Fax 320 0
+64 9 3731710
Email 320 0
c.howe@ctru.auckland.ac.nz

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.