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| ID | Type | Description | Link |
|---|---|---|---|
| NIH RO1 AT000309-01A2 | |||
| UMASS IRB Docket #10225 | |||
| NEIRB Docket #04-039 | |||
| FDA IND #69,292 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Fish Oil |
|
| 2 | Active Comparator | Borage Oil |
|
| 3 | Active Comparator | Fish Oil and Borage Oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fish oil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The modified Disease Activity Score (DAS28) will be the primary outcome measure. | Assessed every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of other medication for RA | Assessed every 3 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert B Zurier, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Arthritis Clinical Intervention Program | Birmingham | Alabama | 35297 | United States | ||
| New England Res. Associates |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2016 | |
| Reset | Nov 7, 2016 | |
| Release | Mar 29, 2018 |
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|
|
| borage seed oil | Drug | Borage oil 13 capsules divided doses daily for 18 months |
|
|
| combination fish oil and borage seed oil | Drug | Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months |
|
|
| Trumbull |
| Connecticut |
| 06611 |
| United States |
| RASF Clinical Research Center | Boca Raton | Florida | 33486 | United States |
| Lake Rheumatology | Tavares | Florida | 32778 | United States |
| Fallon Clinic Health Care | Worcester | Massachusetts | 01605 | United States |
| Division of Rheumatology, Umass Memorial Health Care | Worcester | Massachusetts | 01655 | United States |
| Rheumatology and Internal Medicine Associates of West County, PC | St Louis | Missouri | 63131 | United States |
| Joel M. Kremer | Albany | New York | 12206 | United States |
| Prem Tambar, MD | Niagara Falls | New York | 14303 | United States |
| Bryn Mawr Medical Specialists | Bryn Mawr | Pennsylvania | 19010 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Piedmont Arthritis Clinic | Greenville | South Carolina | 29601 | United States |
| Reset | May 14, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2016 | Nov 7, 2016 | |||
| Mar 29, 2018 | May 14, 2018 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| C079363 | borage oil |
| C014390 | gamma-carboxyglutamyl-gamma-carboxyglutamic acid |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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