Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
5 other identifiers
interventional
156
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Nov 2006
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2003
CompletedFirst Posted
Study publicly available on registry
November 17, 2003
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedAugust 25, 2008
August 1, 2008
1.5 years
November 13, 2003
August 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The modified Disease Activity Score (DAS28) will be the primary outcome measure.
Assessed every 3 months
Secondary Outcomes (1)
Reduction of other medication for RA
Assessed every 3 months
Study Arms (3)
1
ACTIVE COMPARATORFish Oil
2
ACTIVE COMPARATORBorage Oil
3
ACTIVE COMPARATORFish Oil and Borage Oil
Interventions
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.
Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
UAB Arthritis Clinical Intervention Program
Birmingham, Alabama, 35297, United States
New England Res. Associates
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert B Zurier, MD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 13, 2003
First Posted
November 17, 2003
Study Start
November 1, 2006
Primary Completion
May 1, 2008
Study Completion
November 1, 2008
Last Updated
August 25, 2008
Record last verified: 2008-08