Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments fish oil, borage seed oil, combination fish oil and borage seed oil
Phase phase 3
Sponsor National Center for Complementary and Alternative Medicine (NCCAM)
Start date November 2006
End date May 2008
Trial size 156 participants
Trial identifier NCT00072982, FDA IND #69,292, NEIRB Docket #04-039, NIH RO1 AT000309-01A2, R01 AT000309-01A2, UMASS IRB Docket #10225

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Fish Oil
fish oil EPA
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.
(Active Comparator)
Borage Oil
borage seed oil GLA
Borage oil 13 capsules divided doses daily for 18 months
(Active Comparator)
Fish Oil and Borage Oil
combination fish oil and borage seed oil EPA and GLA
Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months

Primary Outcomes

Measure
The modified Disease Activity Score (DAS28) will be the primary outcome measure.
time frame: Assessed every 3 months

Secondary Outcomes

Measure
Reduction of other medication for RA
time frame: Assessed every 3 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
Principal investigator Robert B Zurier, MD
Description See Brief Summary
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by National Center for Complementary and Alternative Medicine (NCCAM).