n-3 and n-6 Fatty Acids in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fish oil, gamma-linolenic acid
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring n-3 fatty acids, n-6 fatty acids, anti-inflammatory action, clinical trial, randomized double-blinded, incorporation of fatty acids
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid or Psoriasis arthritis
Exclusion Criteria:
- Severe diseases of heart, liver, lung airways
- Non-compliance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
Fish oil
Gamma-linolenic Acid
Fish oil plus GLA
Olive oil
Arm Description
3g/d
3g/d gamma-linolenic acid
1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid
3 g/d olive oil
Outcomes
Primary Outcome Measures
incorporation of eicosapentaenoic acid in plasma lipids
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
Secondary Outcome Measures
Disease activity score 28 (DAS28, EULAR)
Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate
C-reactive protein
most common marker of acute systemic inflammation
International Normalized Ratio (INR)
most common single marker for crude quantification of hemostasis
Tolerability
registration of complaints for taste, odor, or mechanical properties of the supplements
Full Information
NCT ID
NCT01179971
First Posted
August 4, 2010
Last Updated
August 25, 2010
Sponsor
Charite University, Berlin, Germany
Collaborators
University of Jena
1. Study Identification
Unique Protocol Identification Number
NCT01179971
Brief Title
n-3 and n-6 Fatty Acids in Rheumatoid Arthritis
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
University of Jena
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
n-3 fatty acids, n-6 fatty acids, anti-inflammatory action, clinical trial, randomized double-blinded, incorporation of fatty acids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Experimental
Arm Description
3g/d
Arm Title
Gamma-linolenic Acid
Arm Type
Experimental
Arm Description
3g/d gamma-linolenic acid
Arm Title
Fish oil plus GLA
Arm Type
Experimental
Arm Description
1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid
Arm Title
Olive oil
Arm Type
Sham Comparator
Arm Description
3 g/d olive oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil, gamma-linolenic acid
Other Intervention Name(s)
Fish oil, omega-6 fatty acids
Intervention Description
3 g/d DHA + EPA
Primary Outcome Measure Information:
Title
incorporation of eicosapentaenoic acid in plasma lipids
Description
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Disease activity score 28 (DAS28, EULAR)
Description
Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate
Time Frame
12 weeks
Title
C-reactive protein
Description
most common marker of acute systemic inflammation
Time Frame
12 weeks
Title
International Normalized Ratio (INR)
Description
most common single marker for crude quantification of hemostasis
Time Frame
12 weeks
Title
Tolerability
Description
registration of complaints for taste, odor, or mechanical properties of the supplements
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid or Psoriasis arthritis
Exclusion Criteria:
Severe diseases of heart, liver, lung airways
Non-compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Stange, MD, PhD
Organizational Affiliation
Immanuel Krankenhaus and Charite Berlin
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21816071
Citation
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.
Results Reference
derived
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n-3 and n-6 Fatty Acids in Rheumatoid Arthritis
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