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. 2018 Nov 30;2018(11):CD003177. doi: 10.1002/14651858.CD003177.pub4

Norwegian 1968.

Methods Norwegian Vegetable Oil Experiment of 1965‐6
RCT, parallel, 2 arms (ALA linseed oil vs omega 6 sunflower oil), 1 year
Risk of bias: moderate or high
Participants Men working in Norwegian companies aged 50‐59 years
N: 6716 intervention, 6690 control
 Level of risk for CVD: low (working men, though a few had had a previous MI or angina)
Men: 100%
Mean age in years (SD): unclear
Age range: 50‐59 years
Smokers: unclear (˜48% non‐smokers)
Hypertension: unclear
Medications taken by at least 50% of those in the control group: not reported
Medications taken by 20%‐49% of those in the control group: not reported
Medications taken by some, but less than 20% of the control group: not reported
Location: Norway
Ethnicity: unclear
Interventions Type: supplementary food (oil)
Comparison: ALA vs omega 6
Intervention: linseed oil, 10 mL/d (55% ALA), 5.5 g/d ALA, 1.5 g/d linoleic. Dose: 5.5 g/d ALA
Control: sunflower oil, 10 mL/d (1.4% ALA), 0.1 g/d ALA, 6.3 g/d linoleic. Vitamin E was added to both oils.
Compliance: 73% were still taking the linseed oil at 1 year, 72% were still taking their sunflower oil at 1 year (unclear how this was ascertained)
Duration of intervention: 12 months
Outcomes Main study outcome: morbidity and mortality
Dropouts: survival status was traced for all but 4 included men, health status was missing for about 80 men in total or 0.6%.
Available outcomes: total and CV deaths, MI, angina, stroke, peripheral vascular disease, combined CV events, total cholesterol (subgroup)
Response to contact: no
Notes Study funding: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Paper states "simple randomisation" without clarification
Allocation concealment (selection bias) Unclear risk Few details provided
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Paper states that the workplace doctors who administered the trial locally were sent bottles for each participant marked only with their trial number, and that "appearance and taste of the products were so similar that most participants were unable to identify the type"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Company physicians recorded health status, and were also blinded to intervention (as above)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Detailed description, and those who left employment during the study were followed up for survival and morbidity via the main health system
Selective reporting (reporting bias) Unclear risk No protocol or trials registration found
Attention Low risk As company physicians administered oils and assessed outcomes but were blind to treatment arm there could not be attention bias
Compliance Unclear risk 73% were still taking the linseed oil at 1 year, 72% were still taking their sunflower oil at 1 year (unclear how this was ascertained)
Other bias Low risk No further bias noted
HHS Vulnerability Disclosure