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

August 25, 2010 updated by: Charite University, Berlin, Germany

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatoid or Psoriasis arthritis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fish oil
3g/d
Dietary supplement: Fish oil, gamma-linolenic acid
3 g/d DHA + EPA
Other Names:
  • Fish oil, omega-6 fatty acids
Experimental: Gamma-linolenic Acid
3g/d gamma-linolenic acid
Dietary supplement: Fish oil, gamma-linolenic acid
3 g/d DHA + EPA
Other Names:
  • Fish oil, omega-6 fatty acids
Experimental: Fish oil plus GLA
1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid
Dietary supplement: Fish oil, gamma-linolenic acid
3 g/d DHA + EPA
Other Names:
  • Fish oil, omega-6 fatty acids
Sham Comparator: Olive oil
3 g/d olive oil
Dietary supplement: Fish oil, gamma-linolenic acid
3 g/d DHA + EPA
Other Names:
  • Fish oil, omega-6 fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incorporation of eicosapentaenoic acid in plasma lipids
Time Frame: 12 weeks
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
C-reactive protein
Time Frame: 12 weeks
most common marker of acute systemic inflammation
12 weeks
International Normalized Ratio (INR)
Time Frame: 12 weeks
most common single marker for crude quantification of hemostasis
12 weeks
Tolerability
Time Frame: 12 weeks
registration of complaints for taste, odor, or mechanical properties of the supplements
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

University of Jena

Investigators

  • Principal Investigator: Rainer Stange, MD, PhD, Immanuel Krankenhaus and Charite Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

August 26, 2010

Last Update Submitted That Met QC Criteria

August 25, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Charite-n-3-n-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Fish oil, gamma-linolenic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe