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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
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 4, 2010
    Last Updated
    August 25, 2010
    Sponsor
    Charite University, Berlin, Germany
    Collaborators
    University of Jena
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    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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