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| Name | Class |
|---|---|
| University of Jena | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil | Experimental | 3g/d |
|
| Gamma-linolenic Acid | Experimental | 3g/d gamma-linolenic acid |
|
| Fish oil plus GLA | Experimental | 1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid |
|
| Olive oil | Sham Comparator | 3 g/d olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil, gamma-linolenic acid | Dietary Supplement | 3 g/d DHA + EPA |
|
| Measure | Description | Time Frame |
|---|---|---|
| incorporation of eicosapentaenoic acid in plasma lipids | ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| C-reactive protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Stange, MD, PhD | Immanuel Krankenhaus and Charite Berlin | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21816071 | Derived | Dawczynski C, Hackermeier U, Viehweger M, Stange R, Springer M, Jahreis G. Incorporation of n-3 PUFA and gamma-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis--a randomized controlled human intervention trial. Lipids Health Dis. 2011 Aug 4;10:130. doi: 10.1186/1476-511X-10-130. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D017965 | gamma-Linolenic Acid |
| D043371 | Fatty Acids, Omega-6 |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D008042 | Linolenic Acids |
| D005228 | Fatty Acids, Essential |
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|
most common marker of acute systemic inflammation
| 12 weeks |
| International Normalized Ratio (INR) | most common single marker for crude quantification of hemostasis | 12 weeks |
| Tolerability | registration of complaints for taste, odor, or mechanical properties of the supplements | 12 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |