Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
NCT ID: NCT00072982
Last Updated: 2008-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
156 participants
INTERVENTIONAL
2006-11-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Fish Oil
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.
2
Borage Oil
borage seed oil
Borage oil 13 capsules divided doses daily for 18 months
3
Fish Oil and Borage Oil
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
Interventions
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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.
borage seed oil
Borage oil 13 capsules divided doses daily for 18 months
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Responsible Party
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University of Massachusetts Medical School
Principal Investigators
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Robert B Zurier, MD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
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UAB Arthritis Clinical Intervention Program
Birmingham, Alabama, United States
New England Res. Associates
Trumbull, Connecticut, United States
RASF Clinical Research Center
Boca Raton, Florida, United States
Lake Rheumatology
Tavares, Florida, United States
Fallon Clinic Health Care
Worcester, Massachusetts, United States
Division of Rheumatology, Umass Memorial Health Care
Worcester, Massachusetts, United States
Rheumatology and Internal Medicine Associates of West County, PC
St Louis, Missouri, United States
Joel M. Kremer
Albany, New York, United States
Prem Tambar, MD
Niagara Falls, New York, United States
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Piedmont Arthritis Clinic
Greenville, South Carolina, United States
Countries
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Other Identifiers
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NIH RO1 AT000309-01A2
Identifier Type: -
Identifier Source: secondary_id
UMASS IRB Docket #10225
Identifier Type: -
Identifier Source: secondary_id
NEIRB Docket #04-039
Identifier Type: -
Identifier Source: secondary_id
FDA IND #69,292
Identifier Type: -
Identifier Source: secondary_id