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

NCT ID: NCT01179971

Last Updated: 2010-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fish oil

3g/d

Group Type EXPERIMENTAL

Fish oil, gamma-linolenic acid

Intervention Type DIETARY_SUPPLEMENT

3 g/d DHA + EPA

Gamma-linolenic Acid

3g/d gamma-linolenic acid

Group Type EXPERIMENTAL

Fish oil, gamma-linolenic acid

Intervention Type DIETARY_SUPPLEMENT

3 g/d DHA + EPA

Fish oil plus GLA

1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid

Group Type EXPERIMENTAL

Fish oil, gamma-linolenic acid

Intervention Type DIETARY_SUPPLEMENT

3 g/d DHA + EPA

Olive oil

3 g/d olive oil

Group Type SHAM_COMPARATOR

Fish oil, gamma-linolenic acid

Intervention Type DIETARY_SUPPLEMENT

3 g/d DHA + EPA

Interventions

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Fish oil, gamma-linolenic acid

3 g/d DHA + EPA

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fish oil, omega-6 fatty acids

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid or Psoriasis arthritis

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Abteilung für Naturheilkunde Charité

Principal Investigators

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Rainer Stange, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Immanuel Krankenhaus and Charite Berlin

References

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Dawczynski C, Hackermeier U, Viehweger M, Stange R, Springer M, Jahreis G. Incorporation of n-3 PUFA and gamma-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis--a randomized controlled human intervention trial. Lipids Health Dis. 2011 Aug 4;10:130. doi: 10.1186/1476-511X-10-130.

Reference Type DERIVED
PMID: 21816071 (View on PubMed)

Other Identifiers

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Charite-n-3-n-6

Identifier Type: -

Identifier Source: org_study_id

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