Treatment of Rheumatoid Arthritis With Marine and Botanical Oils - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00072982

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: fish oil Drug: borage seed oil Drug: combination fish oil and borage seed oil	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Borage oil Fish oil

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

The modified Disease Activity Score (DAS28) will be the primary outcome measure. [ Time Frame: Assessed every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of other medication for RA [ Time Frame: Assessed every 3 months ] [ Designated as safety issue: No ]

Enrollment:	156
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator Borage Oil	Drug: borage seed oil Borage oil 13 capsules divided doses daily for 18 months
3: Active Comparator 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

Detailed Description:

See Brief Summary

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Lake Rheumatology
Tavares, Florida, United States, 32778
RASF Clinical Research Center
Boca Raton, Florida, United States, 33486
United States, Massachusetts
Division of Rheumatology, Umass Memorial Health Care
Worcester, Massachusetts, United States, 01655
Fallon Clinic Health Care
Worcester, Massachusetts, United States, 01605
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
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, United States, 19010
United States, South Carolina
Piedmont Arthritis Clinic
Greenville, South Carolina, United States, 29601

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Robert B Zurier, MD

University of Massachusetts Medical School

More Information

No publications provided

Responsible Party:	University of Massachusetts Medical School ( Robert B. Zurier, MD )
Study ID Numbers:	R01 AT000309-01A2, NIH RO1 AT000309-01A2, UMASS IRB Docket #10225, NEIRB Docket #04-039, FDA IND #69,292
Study First Received:	November 13, 2003
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00072982 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Fish oil
Borage oil

Additional relevant MeSH terms:

Borage oil
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Therapeutic Uses
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010