Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Rheumatoid Arthritis Clinical Trial

Official title:

Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00072982
• Other study ID #: R01AT000309-01A2
• Secondary ID: NIH RO1 AT000309
• Status: Unknown status
• Phase: Phase 3
• First received: November 13, 2003
• Last updated: August 22, 2008
• Start date: November 2006
• Est. completion date: November 2008

Study information

• Verified date: August 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 156
• Est. completion date: November 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• borage seed oil
Borage oil 13 capsules divided doses daily for 18 months
• 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

Locations

Country	Name	City	State
United States	Joel M. Kremer	Albany	New York
United States	UAB Arthritis Clinical Intervention Program	Birmingham	Alabama
United States	RASF Clinical Research Center	Boca Raton	Florida
United States	Bryn Mawr Medical Specialists	Bryn Mawr	Pennsylvania
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Piedmont Arthritis Clinic	Greenville	South Carolina
United States	Prem Tambar, MD	Niagara Falls	New York
United States	Rheumatology and Internal Medicine Associates of West County, PC	St. Louis	Missouri
United States	Lake Rheumatology	Tavares	Florida
United States	New England Res. Associates	Trumbull	Connecticut
United States	Division of Rheumatology, Umass Memorial Health Care	Worcester	Massachusetts
United States	Fallon Clinic Health Care	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The modified Disease Activity Score (DAS28) will be the primary outcome measure.		Assessed every 3 months
Secondary	Reduction of other medication for RA		Assessed every 3 months