Version 2.5.2.0

Abstract

Grant Number:	5R01AT000309-03
Project Title:	Treatment of Rheumatoid Arthritis-Marine/Botanical Oils

PI Information:	Name	Email	Title
	ZURIER, ROBERT B.	robert.zurier@umassmed.edu	PROFESSOR OF MEDICINE, DIRECTOR

Abstract: DESCRIPTION (provided by applicant): The object of this proposal 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. Fish oil is rich in the antiinflammatory n3 unsaturated fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and borage oil contains gammalinolenic acid (GLA), an n6 unsaturated fatty acid with antiinflammatory and immunomodulatory properties. Administration of borage oil and of fish oil both suppress the clinical manifestations of RA. Animal studies indicate that the mechanisms whereby fish oil suppresses inflammation are both similar to and different from the means by which GLA reduces inflammation and that the combination treatment is more effective than each treatment alone. This proposal is for a multi-center, two-year, phase 3, double-masked, placebo-controlled trial of 375 patients, which includes 4 treatment groups: 1) corn oil as a polyunsaturated fatty acid control; 2) fish oil; 3) borage oil; 4) fish oil plus borage oil. Radiographic analysis (Sharp Scores) of hands and feet will be done at baseline, 12, and 24 months. Biochemical and molecular mechanisms whereby the fatty acid treatments influence activation of monocytes (cytokine and oxygen radical generation), and T lymphocytes (proliferation, cytokine production, Th1/Th2 skewing, signaling events) will be investigated. Results of the cell activation (ex vivo) studies will be correlated with clinical outcomes. Results of these studies should raise awareness of the usefulness of naturally occurring oils in inflammatory diseases, lead to more rational use of fatty acids in treatment of inflammatory arthritis, and provide a greater understanding of the mechanisms of action of antiinflammatory fatty acids.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
arthritis therapy, diet therapy, dietary supplement, marine animal oil, plant extract, rheumatoid arthritis
T lymphocyte, arachidonate, clinical trial phase III, gene expression, human therapy evaluation, inflammation, omega 3 fatty acid, tumor necrosis factor alpha
alternative medicine, clinical research, human subject, nutrition related tag, patient oriented research, radiography

Institution:	UNIV OF MASSACHUSETTS MED SCH WORCESTER
	WORCESTER, MA 01655
Fiscal Year:	2005
Department:	MEDICINE
Project Start:	01-SEP-2003
Project End:	31-MAY-2007
ICD:	NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE
IRG:	ZAT1

---