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. 2018 Jul 18;2018(7):CD003177. doi: 10.1002/14651858.CD003177.pub3
Methods RCT, parallel, (EPA + DHA vs unclear), 24 months
Summary risk of bias: moderate or high
Participants Adults with Metabolic syndrome
N: unclear, total randomised 101
Level of risk for CVD: low
Men: 47% total, no details by group
Mean age in years (SD): 55 (10) total
Age range: 18‐75 years
Smokers: 0% intervention, 0% control
Hypertension: not reported
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: USA
Ethnicity: unclear
Interventions Type: supplement (fish oil capsules)
Comparison: EPA + DHA vs placebo (unclear what)
Intervention: fO3FA capsules 1.8 g of EPA + DHA daily. Dose: 1.8 g/d EPA + DHA
Control: matching placebo supplement
Compliance: not reported
Length of intervention: 12 months
Outcomes Main study outcome: change in carotid IMT
Dropouts: unclear
Available outcomes: lipids, insulin and glucose are stated as secondary outcomes but no usable data published
Response to contact: no
Notes Results cannot be used as numbers are not reported by study arm.
Study funding: unclear, but mentions that Pfizer, NIH and "Northwest Lipids Clinic" are partners
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details
Allocation concealment (selection bias) Unclear risk No details
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No data
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No data
Incomplete outcome data (attrition bias) All outcomes Unclear risk No data
Selective reporting (reporting bias) High risk Inadequate detail in reporting as no full text publication found; Gill 2014 does give detail on carotid IMT, but not on other primary or secondary outcomes. The trial was prospectively registered (registered July 2006, unclear when recruitment started, final data collection 2011, first data published 2012).
Attention Unclear risk No data
Compliance Unclear risk No data
Other bias Unclear risk No data