Rheumatoid Arthritis
Conditions
Keywords
Fish oil, Borage oil
Brief 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.
Detailed description
See Brief Summary
Interventions
DRUGfish 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.
DRUGborage seed oil
Borage oil 13 capsules divided doses daily for 18 months
DRUGcombination 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
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The modified Disease Activity Score (DAS28) will be the primary outcome measure. | Assessed every 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of other medication for RA | Assessed every 3 months |
Countries
United States
Outcome results
None listed