Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

August 22, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)
The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. This study will also investigate the biochemical, immunological, and molecular mechanism responsible for the therapeutic effects of these fatty acids. Each patient will be followed for eighteen months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

See Brief Summary

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35297
        • UAB Arthritis Clinical Intervention Program
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • New England Res. Associates
    • Florida
      • Boca Raton, Florida, United States, 33486
        • RASF Clinical Research Center
      • Tavares, Florida, United States, 32778
        • Lake Rheumatology
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Fallon Clinic Health Care
      • Worcester, Massachusetts, United States, 01655
        • Division of Rheumatology, Umass Memorial Health Care
    • Missouri
      • St. Louis, Missouri, United States, 63131
        • Rheumatology and Internal Medicine Associates of West County, PC
    • New York
      • Albany, New York, United States, 12206
        • Joel M. Kremer
      • Niagara Falls, New York, United States, 14303
        • Prem Tambar, MD
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Medical Specialists
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Piedmont Arthritis Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Definite RA with onset at > 16 years, with total disease duration of at least 6 months
  • Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate >_28, or a CRP >1.4, or morning stiffness of at least 45 min
  • Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos.
  • All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos
  • Stable NSAID for 1 month before baseline if on an NSAID
  • Stable prednisone dose of < 10 mg/day for 1 month before baseline visit, if on prednisone
  • Ability to give and understand all elements of informed consent
  • Absence of comorbid condition which, in the opinion of the physician-investigator, would render the patient unsuitable for the study
  • Willingness to adhere to the clinical protocol.

Exclusion Criteria

  • A diagnosis of inflammatory arthritis other than rheumatoid arthritis
  • Chronic anticoagulation
  • Hypersensitivity to fish or fish products or plant products
  • A dose of prednisone of > 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation
  • An inability or unwillingness to use an effective form of contraception (females) during the duration of the study
  • Pregnant and breast-feeding females
  • Inability or unwillingness to adhere to the study diet
  • Platelet count < 100,000/mm 3
  • Hemoglobin < 9 g/dl
  • Albumin < 3.3 g

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Fish Oil
Drug: fish oil
The object of this intervention is to determine whether treatment of rheumatoid arthritis with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Each arm of the study will take 13 capsules daily (divided doses) for 18 months.
Other Names:
  • EPA
Active Comparator: 2
Borage Oil
Drug: borage seed oil
Borage oil 13 capsules divided doses daily for 18 months
Other Names:
  • GLA
Active Comparator: 3
Fish Oil and Borage Oil
Drug: combination fish oil and borage seed oil
Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months
Other Names:
  • EPA and GLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The modified Disease Activity Score (DAS28) will be the primary outcome measure.
Time Frame: Assessed every 3 months
Assessed every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of other medication for RA
Time Frame: Assessed every 3 months
Assessed every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Robert B Zurier, MD, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

November 13, 2003

First Submitted That Met QC Criteria

November 14, 2003

First Posted (Estimate)

November 17, 2003

Study Record Updates

Last Update Posted (Estimate)

August 25, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT000309-01A2 (U.S. NIH Grant/Contract)
  • NIH RO1 AT000309-01A2
  • UMASS IRB Docket #10225
  • NEIRB Docket #04-039
  • FDA IND #69,292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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