Incorporation of n-3 Long Chain Polyunsaturated Fatty Acids and Gamma Linolenic Acid in Plasma Lipids, Cholesteryl Esters, and Erythrocyte Membranes and Their Influence on Disease Activity in Patients With Rheumatoid Arthritis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Primary Endpoint
- incorporation of eicosapentaenoic acid in plasma lipids
Study Overview
Brief Summary
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).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Rheumatoid or Psoriasis arthritis
Exclusion Criteria
- •Severe diseases of heart, liver, lung airways
- •Non-compliance
Outcomes
Primary Outcomes
incorporation of eicosapentaenoic acid in plasma lipids
Time Frame: 12 weeks
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
Secondary Outcomes
- Disease activity score 28 (DAS28, EULAR)(12 weeks)
- C-reactive protein(12 weeks)
- International Normalized Ratio (INR)(12 weeks)
- Tolerability(12 weeks)