n-3 and n-6 Fatty Acids in Rheumatoid Arthritis - Full Text View

Purpose

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).

Condition	Intervention	Phase
Rheumatoid Arthritis	Dietary Supplement: Fish oil, gamma-linolenic acid	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Linolenic acid Fish oil

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

incorporation of eicosapentaenoic acid in plasma lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids

Secondary Outcome Measures:

Disease activity score 28 (DAS28, EULAR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate
C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
most common marker of acute systemic inflammation
International Normalized Ratio (INR) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
most common single marker for crude quantification of hemostasis
Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
registration of complaints for taste, odor, or mechanical properties of the supplements

Enrollment:	60
Study Start Date:	December 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fish oil 3g/d	Dietary Supplement: Fish oil, gamma-linolenic acid 3 g/d DHA + EPA Other Name: 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 Name: 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 Name: 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 Name: Fish oil, omega-6 fatty acids

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Rheumatoid or Psoriasis arthritis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179971

Sponsors and Collaborators

Charite University, Berlin, Germany

University of Jena

Investigators

Principal Investigator:

Rainer Stange, MD, PhD

Immanuel Krankenhaus and Charite Berlin

More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dawczynski C, Hackermeier U, Viehweger M, Stange R, Springer M, Jahreis G. Incorporation of n-3 PUFA and ?-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.

Responsible Party:	Rainer Stange, M.D. Ph.D., Abteilung für Naturheilkunde Charité
ClinicalTrials.gov Identifier:	NCT01179971 History of Changes
Other Study ID Numbers:	Charite-n-3-n-6
Study First Received:	August 4, 2010
Last Updated:	August 25, 2010
Health Authority:	Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by Charite University, Berlin, Germany:

n-3 fatty acids
n-6 fatty acids
anti-inflammatory action

clinical trial
randomized double-blinded
incorporation of fatty acids

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Efamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013