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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: Fish oil, gamma-linolenic acid

• Registration Number: NCT01179971
• Lead Sponsor: Charite University, Berlin, Germany

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 Timeline

• Study Start: 2008-12
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-08
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Last Update Submitted: 2010-08-25
• Last Update Posted: 2010-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Rheumatoid or Psoriasis arthritis

Exclusion Criteria

• Severe diseases of heart, liver, lung airways
• Non-compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil	Fish oil, gamma-linolenic acid	3g/d
Gamma-linolenic Acid	Fish oil, gamma-linolenic acid	3g/d gamma-linolenic acid
Fish oil plus GLA	Fish oil, gamma-linolenic acid	1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid
Olive oil	Fish oil, gamma-linolenic acid	3 g/d olive oil

Primary Outcome Measures

Name	Time	Method
incorporation of eicosapentaenoic acid in plasma lipids	12 weeks	ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids

Secondary Outcome Measures

Name	Time	Method
Disease activity score 28 (DAS28, EULAR)	12 weeks	Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate
C-reactive protein	12 weeks	most common marker of acute systemic inflammation
International Normalized Ratio (INR)	12 weeks	most common single marker for crude quantification of hemostasis
Tolerability	12 weeks	registration of complaints for taste, odor, or mechanical properties of the supplements