FOILS
Fish Oils (Omega 3) in ischaemic stroke
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Purpose:
To evaluate the effectiveness of Omega-3 PUFAs in improving lipid profiles
Year Started:
2004
Year Finished:
2006
Design:
Interventional, Treatment, Randomised controlled trial
Inclusion Criteria
1. CT confirmed first-ever or recurrent ischaemic stroke 2. Clinically stable with atheromatous disease history greater than 3 months.
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.
Patient Involvement:
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.
Primary Outcome:
To evaluate the effectiveness of Omega-3 PUFAs in improving lipid profiles
Secondary Outcome:
To evaluate the treatment on changes in weight, blood pressure, inflammatory and haemostatic markers of cardiovascular disease, and mood, 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).
Results:
One hundred two patients were randomized to fish oil or placebo. Intention-to-treat and per-protocol (>85% compliance) analyses showed no significant effect of fish oil treatment on any lipid, inflammatory, hemostatic, or composite mood parameters measured. Adherence to treatment based on pill count was good (89%) reflected by increased serum docosahexanoic acid (P<0.001) and eicosapentaenoic acid (P=0.0006) in the fish oil group. Analysis of oil composition, however, showed some degradation and potentially adverse oxidation products at the end of the study. In conclusion, there was no effect of 12 weeks of treatment with moderate-dose fish oil supplements on cardiovascular biomarkers or mood in patients with ischemic stroke. It is possible that insufficient dose, short duration of treatment, and/or oxidation of the fish oils may have influenced these outcomes.
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Source of Information:
Australian New Zealand Clinical Trials Registry
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Web Links and Publications:
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This information last updated on: 11/6/2009
Reviewed on: 10/30/2009.
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