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Completed

NCT Number: NCT01179971

n-3 and n-6 Fatty Acids in 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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rheumatoid or Psoriasis arthritis

Exclusion criteria

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

Treatment and study plan

Fish oil, gamma-linolenic acid

Dietary Supplement

3 g/d DHA + EPA

Other names: Fish oil, omega-6 fatty acids

Primary outcomes

  1. incorporation of eicosapentaenoic acid in plasma lipids

    Time frame: 12 weeks

    ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids

Secondary outcomes

  1. Disease activity score 28 (DAS28, EULAR)

    Time frame: 12 weeks

    Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate

  2. C-reactive protein

    Time frame: 12 weeks

    most common marker of acute systemic inflammation

  3. International Normalized Ratio (INR)

    Time frame: 12 weeks

    most common single marker for crude quantification of hemostasis

  4. Tolerability

    Time frame: 12 weeks

    registration of complaints for taste, odor, or mechanical properties of the supplements

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • University of Jena

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2010
Registry last updated
Aug 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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