n-3 and n-6 Fatty Acids in Rheumatoid Arthritis

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.

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

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Fish oil, gamma-linolenic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid or Psoriasis arthritis Exclusion Criteria: Severe diseases of heart, liver, lung airways Non-compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil<br>3g/d | Dietary Supplement: Fish oil, gamma-linolenic acid<br>* 3 g/d DHA + EPA<br>* Other names: Fish oil, omega-6 fatty acids;|
| Experimental: Gamma-linolenic Acid<br>3g/d gamma-linolenic acid | Dietary Supplement: Fish oil, gamma-linolenic acid<br>* 3 g/d DHA + EPA<br>* Other names: Fish oil, omega-6 fatty acids;|
| Experimental: Fish oil plus GLA<br>1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid | Dietary Supplement: Fish oil, gamma-linolenic acid<br>* 3 g/d DHA + EPA<br>* Other names: Fish oil, omega-6 fatty acids;|
| Sham Comparator: Olive oil<br>3 g/d olive oil | Dietary Supplement: Fish oil, gamma-linolenic acid<br>* 3 g/d DHA + EPA<br>* Other names: Fish oil, omega-6 fatty acids;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incorporation of eicosapentaenoic acid in plasma lipids | ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
n-3 fatty acids, n-6 fatty acids, anti-inflammatory action, clinical trial, randomized double-blinded, incorporation of fatty acids