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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003177. doi: 10.1002/14651858.CD003177.pub2
Methods Randomisation: manufacturer provided envelopes containing numbers corresponding to boxes of capsules, for each enrolled participant a random envelope was opened
Allocation concealment: Done
Participants masked: No (‘you can taste the fish oil’)
Providers masked: Unclear
Outcome assessors masked: yes
Summary risk of bias: medium or high
Participants N: 15 low dose, 15 medium dose, 14 high dose, 14 control
Level of risk for CVD: Low (healthy monks)
Male: 100%
Mean age, sd: overall: 56.2, 16.5
Age range: Unclear
Smokers: Unclear
Hypertension: None
Location: The Netherlands
Interventions Type: supplement (capsule)
Intervention: Fish oil capsules, all took 9 per day, double dummy, some with Olive and palm oil capsules (1.1g omega-3 fats low dose, 2.2g medium dose, 3.3g high dose per day)
Control: 9 Olive and palm oil capsules (0g omega-3 fats per day)
Compliance: ‘excellent’ in all groups according to capsule count, plasma cholesteryl esters rose from 0.8 to 3.8 low intake, 0.9 to 6.6 medium intake, 0.7 to 10.4 high intake and 0.9 to 0.9 control group from 0 to 12 mo.
Length of intervention: 12 mo
Outcomes Main study outcome: tissue incorporation
Dropouts: none?
Available outcomes: deaths, lipids, blood pressure
Response to contact: yes
Notes Dietary assessment suggested that total diet plus supplement intakes were as follows 1.5g/d EPA + DHA + DPA low intake, 2.5g/d medium intake, 3.6g/d high intake, 0.4g/d control group
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Yes A - Adequate