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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000211
ACTR Number: ACTRN12605000207617
Trial Status: Registered
Date Submitted: 17/08/2005
Date Registered: 25/08/2005

Page 1

Public title: Fish Oils (Omega 3) in ischaemic stroke
ANZCTR registration title: A Randomised, Placebo-Controlled Intervention Trial of Omega-3 PUFA, (Fish Oils), in People with Ischaemic Stroke
Secondary ID: 
UTN:
Trial acronym: FOILS

Page 2

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

Page 3

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:None 
Comparator / control treatment: Placebo (palm and soy oil) for the control group for 12 weeks.
Control group: Placebo

Page 4

Primary outcome:To evaluate the effectiveness of Omega-3 PUFAs in improving lipid profiles 
Timepoint:At 12 weeks 
Secondary outcome 1:To evaluate the treatment on changes in weight, blood pressure, inflammatory and haemostatic markers of cardiovascular disease, and mood. 
Timepoint:The study will provide efficacy and tolerability data on the study treatment given for a total of 12 weeks. 
Secondary outcome 2: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:Will be collected at baseline and 12 weeks. 

Page 5

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
Gender: Both males and females
Healthy volunteers? 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.

Page 6
Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): sealed numbered envelopes.
Describe the 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: The people receiving the treatment/s
 The people administering the treatment/s
 The people assessing the outcomes
 The people analysing the results/data
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Safety/efficacy

Page 7
Phase Phase 2 / Phase 3
Anticipated or actual start date: 1/06/2004
Target sample size: 220
Recruitment status: Completed

Page 8

Funding source:Government funding body e.g. Australian Research Council 
Name:Health Research Council 
Address:Level 3, 110 Stanley Street, Auckland, 1010, New Zealand 
Country:New Zealand 
Primary sponsor: Government funding body e.g. Department of Health
Name: Health Research Council (New Zealand)
Address: Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
Country: New Zealand
Secondary sponsor:University 
Name:CTRU, The University of Auckland 
Address:Level 4, School of Population Health, Tamaki Campus, University of Auckland, Glen Innes, Auckland 1072 
Country:New Zealand 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Auckland 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Countries of recruitment:Outside Australia 
New Zealand 
Brief summary:
Trial website:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Dr Colin Howe
Address: Clinical Trials Reseach Unit University of Auckland Private Bag 92019 Glen Innes Auckland 1
Country: New Zealand
Tel: +64 9 3737999
Fax: +64 9 3731710
Email: c.howe@ctru.auckland.ac.nz

Contact person for scientific queries
Name: Dr Colin Howe
Address: Clinical Trials Reseach Unit University of Auckland Private Bag 92019 Glen Innes Auckland 1
Country: New Zealand
Tel: +64 9 3737999
Fax: +64 9 3731710
Email: c.howe@ctru.auckland.ac.nz

Contact person responsible for updating information
Name:
Address:
Country:
Tel:
Fax:
Email: regtrials@ctru.auckland.ac.nz
   
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