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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01179971

Enrollment

Registered

2010-08-11

Start date

2008-12-31

Completion date

2010-01-31

Last updated

2010-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

n-3 fatty acids, n-6 fatty acids, anti-inflammatory action, clinical trial, randomized double-blinded, incorporation of fatty acids

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.

Interventions

DIETARY_SUPPLEMENTFish oil, gamma-linolenic acid

3 g/d DHA + EPA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Rheumatoid or Psoriasis arthritis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
incorporation of eicosapentaenoic acid in plasma lipids	12 weeks	ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026