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

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

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Fish oil Borage oil

U.S. FDA Resources

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

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

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
First Received:	November 13, 2003
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00072982
Health Authority:	United States: Food and Drug Administration

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

Fish oil

Borage oil

Study placed in the following topic categories:

Borage oil

Autoimmune Diseases

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

Therapeutic Uses

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

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