Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
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| ClinicalTrials.gov Identifier: NCT00072982 |
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Recruitment Status : Unknown
Verified August 2008 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was: Active, not recruiting
First Posted : November 17, 2003
Last Update Posted : August 25, 2008
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Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: fish oil Drug: borage seed oil Drug: combination fish oil and borage seed oil | Phase 3 |
See Brief Summary
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 156 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Rheumatoid Arthritis With Marine and Botanical Oils |
| Study Start Date : | November 2006 |
| Actual Primary Completion Date : | May 2008 |
| Estimated Study Completion Date : | November 2008 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Fish Oil
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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.
Other Name: EPA |
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Active Comparator: 2
Borage Oil
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Drug: borage seed oil
Borage oil 13 capsules divided doses daily for 18 months
Other Name: GLA |
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Active Comparator: 3
Fish Oil and Borage Oil
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Drug: 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
Other Name: EPA and GLA |
Primary Outcome Measures :
- The modified Disease Activity Score (DAS28) will be the primary outcome measure. [ Time Frame: Assessed every 3 months ]
Secondary Outcome Measures :
- Reduction of other medication for RA [ Time Frame: Assessed every 3 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072982
Locations
| United States, Alabama | |
| UAB Arthritis Clinical Intervention Program | |
| Birmingham, Alabama, United States, 35297 | |
| United States, Connecticut | |
| New England Res. Associates | |
| Trumbull, Connecticut, United States, 06611 | |
| United States, Florida | |
| RASF Clinical Research Center | |
| Boca Raton, Florida, United States, 33486 | |
| Lake Rheumatology | |
| Tavares, Florida, United States, 32778 | |
| United States, Massachusetts | |
| Fallon Clinic Health Care | |
| Worcester, Massachusetts, United States, 01605 | |
| Division of Rheumatology, Umass Memorial Health Care | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Missouri | |
| Rheumatology and Internal Medicine Associates of West County, PC | |
| St. Louis, Missouri, United States, 63131 | |
| United States, New York | |
| Joel M. Kremer | |
| Albany, New York, United States, 12206 | |
| Prem Tambar, MD | |
| Niagara Falls, New York, United States, 14303 | |
| United States, Pennsylvania | |
| Bryn Mawr Medical Specialists | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, South Carolina | |
| Piedmont Arthritis Clinic | |
| Greenville, South Carolina, United States, 29601 | |
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
| Principal Investigator: | Robert B Zurier, MD | University of Massachusetts, Worcester |
| Responsible Party: | Robert B. Zurier, MD, University of Massachusetts Medical School |
| ClinicalTrials.gov Identifier: | NCT00072982 History of Changes |
| Other Study ID Numbers: |
R01AT000309-01A2 ( U.S. NIH Grant/Contract ) NIH RO1 AT000309-01A2 UMASS IRB Docket #10225 NEIRB Docket #04-039 FDA IND #69,292 |
| First Posted: | November 17, 2003 Key Record Dates |
| Last Update Posted: | August 25, 2008 |
| Last Verified: | August 2008 |
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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Fish oil Borage oil |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Borage oil Antirheumatic Agents |