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

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Dietary Supplement: Fish oil, gamma-linolenic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01179971
Charite-n-3-n-6

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Rheumatoid or Psoriasis arthritis

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 4 patient groups

Fish oil
Experimental group
Description:
3g/d
Treatment:
Dietary Supplement: Fish oil, gamma-linolenic acid
Gamma-linolenic Acid
Experimental group
Description:
3g/d gamma-linolenic acid
Treatment:
Dietary Supplement: Fish oil, gamma-linolenic acid
Fish oil plus GLA
Experimental group
Description:
1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid
Treatment:
Dietary Supplement: Fish oil, gamma-linolenic acid
Olive oil
Sham Comparator group
Description:
3 g/d olive oil
Treatment:
Dietary Supplement: Fish oil, gamma-linolenic acid

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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