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Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

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ClinicalTrials.gov Identifier: NCT00072982
Recruitment Status : Unknown
Verified August 2008 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2003
Last Update Posted : August 25, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: fish oil Drug: borage seed oil Drug: combination fish oil and borage seed oil Phase 3

Detailed Description:
See Brief Summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
Study Start Date : November 2006
Actual Primary Completion Date : May 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


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 Name: EPA

Active Comparator: 2
Borage Oil
Drug: borage seed oil
Borage oil 13 capsules divided doses daily for 18 months
Other Name: 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 Name: EPA and GLA




Primary Outcome Measures :
  1. The modified Disease Activity Score (DAS28) will be the primary outcome measure. [ Time Frame: Assessed every 3 months ]

Secondary Outcome Measures :
  1. Reduction of other medication for RA [ Time Frame: Assessed every 3 months ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072982


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

Responsible Party: Robert B. Zurier, MD, University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT00072982     History of Changes
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
First Posted: November 17, 2003    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Fish oil
Borage oil

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Borage oil
Antirheumatic Agents