Status:
UNKNOWN
Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 wi...
Detailed Description
See Brief Summary
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00072982
Start Date
November 1 2006
End Date
November 1 2008
Last Update
August 25 2008
Active Locations (13)
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1
UAB Arthritis Clinical Intervention Program
Birmingham, Alabama, United States, 35297
2
New England Res. Associates
Trumbull, Connecticut, United States, 06611
3
RASF Clinical Research Center
Boca Raton, Florida, United States, 33486
4
Lake Rheumatology
Tavares, Florida, United States, 32778