| November 13, 2003 |
| August 22, 2008 |
| November 2006 |
| May 2008 (final data collection date for primary outcome measure) |
| The modified Disease Activity Score (DAS28) will be the primary outcome measure. [ Time Frame: Assessed every 3 months ] [ Designated as safety issue: No ] |
| The modified Disease Activity Score (DAS28) will be the primary outcome measure. |
| Complete list of historical versions of study NCT00072982 on ClinicalTrials.gov Archive Site |
| Reduction of other medication for RA [ Time Frame: Assessed every 3 months ] [ Designated as safety issue: No ] |
| Reduction of other medication for RA |
| |
| Treatment of Rheumatoid Arthritis With Marine and Botanical Oils |
| Treatment of Rheumatoid Arthritis With Marine and Botanical Oils |
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. |
See Brief Summary |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Rheumatoid Arthritis |
- Drug: fish oil
- Drug: borage seed oil
- Drug: combination fish oil and borage seed oil
|
- Active Comparator: Fish Oil
- Active Comparator: Borage Oil
- Active Comparator: Fish Oil and Borage Oil
|
| |
| |
| Active, not recruiting |
| 156 |
| November 2008 |
| May 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 85 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00072982 |
| Robert B. Zurier, MD, University of Massachusetts Medical School |
| R01 AT000309-01A2, NIH RO1 AT000309-01A2, UMASS IRB Docket #10225, NEIRB Docket #04-039, FDA IND #69,292 |
| National Center for Complementary and Alternative Medicine (NCCAM) |
|
| Principal Investigator: |
Robert B Zurier, MD |
University of Massachusetts Medical School |
|
|
| National Center for Complementary and Alternative Medicine (NCCAM) |
| August 2008 |
