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 |
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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 |
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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 |
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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 |
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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 |