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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179971
• Other study ID #: Charite-n-3-n-6
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2010
• Last updated: August 25, 2010
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: August 2010
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Fish oil, gamma-linolenic acid
3 g/d DHA + EPA

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	University of Jena

Outcome

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