Rheumatoid Arthritis Clinical Trial
Official title:
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
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Rheumatoid or Psoriasis arthritis Exclusion Criteria: - Severe diseases of heart, liver, lung airways - Non-compliance |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | University of Jena |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incorporation of eicosapentaenoic acid in plasma lipids | ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids | 12 weeks | No |
Secondary | Disease activity score 28 (DAS28, EULAR) | Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate | 12 weeks | No |
Secondary | C-reactive protein | most common marker of acute systemic inflammation | 12 weeks | No |
Secondary | International Normalized Ratio (INR) | most common single marker for crude quantification of hemostasis | 12 weeks | Yes |
Secondary | Tolerability | registration of complaints for taste, odor, or mechanical properties of the supplements | 12 weeks | Yes |
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