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
1 other identifier
interventional
60
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Dec 2008
Shorter than P25 for phase_2 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 4, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedAugust 26, 2010
August 1, 2010
1.1 years
August 4, 2010
August 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incorporation of eicosapentaenoic acid in plasma lipids
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
12 weeks
Secondary Outcomes (4)
Disease activity score 28 (DAS28, EULAR)
12 weeks
C-reactive protein
12 weeks
International Normalized Ratio (INR)
12 weeks
Tolerability
12 weeks
Study Arms (4)
Fish oil
EXPERIMENTAL3g/d
Gamma-linolenic Acid
EXPERIMENTAL3g/d gamma-linolenic acid
Fish oil plus GLA
EXPERIMENTAL1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid
Olive oil
SHAM COMPARATOR3 g/d olive oil
Interventions
3 g/d DHA + EPA
Eligibility Criteria
You may qualify if:
- Rheumatoid or Psoriasis arthritis
You may not qualify if:
- Severe diseases of heart, liver, lung airways
- Non-compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- University of Jenacollaborator
Related Publications (1)
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.
PMID: 21816071DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rainer Stange, MD, PhD
Immanuel Krankenhaus and Charite Berlin
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 4, 2010
First Posted
August 11, 2010
Study Start
December 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
August 26, 2010
Record last verified: 2010-08