Purpose: To investigate into the differential effects of polyunsaturated fatty acids as compared to standard control therapy (olive oil) on disease activity and biochemical parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).
Methods: Double-blinded, four-armed randomised controlled trial with 3.0 g/d of either n-3 long chain polyunsaturated fatty acids (LC-PUFA) or gamma linolenic acid (GLA), resp. the combination of 1.5 g/d of each, resp. 3.0 g/d of olive oil over 12 weeks. Outcome parameters disease activity score (DAS28), C-reactive protein, concentrations of n-3 LC-PUFA, resp. GLA in plasma lipids (PL), cholesterol esters (CE), and erythrocyte membranes (EM), and serum concentrations of arachidonic acid (AA). Conventional antirheumatic and immunosuppressive therapies could be changed only within defined limits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
3 g/d DHA + EPA
incorporation of eicosapentaenoic acid in plasma lipids
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
Time frame: 12 weeks
Disease activity score 28 (DAS28, EULAR)
Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate
Time frame: 12 weeks
C-reactive protein
most common marker of acute systemic inflammation
Time frame: 12 weeks
International Normalized Ratio (INR)
most common single marker for crude quantification of hemostasis
Time frame: 12 weeks
Tolerability
registration of complaints for taste, odor, or mechanical properties of the supplements
Time frame: 12 weeks
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