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

This study has been completed.
Sponsor:
Collaborator:
University of Jena
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01179971
First received: August 4, 2010
Last updated: August 25, 2010
Last verified: August 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 August 28, 2014