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Home > "T" Clinical Trials Conditions > Treatment of Rheumatoid Arthritis with Marine and Botanical Oils  Treatment of Rheumatoid Arthritis with Marine and Botanical Oils
Treatment of Rheumatoid Arthritis with Marine and Botanical Oils
For Condition: Rheumatoid Arthritis
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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 two years.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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 aretender 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
Total Enrollment: 375
Location and Contact Information:
Overall Study Official:
RobertZurier, Principal Investigator, University of Massachusetts Medical School
Long Island College Hospital
Brooklyn, New York, 11201
United States
Allan Gibofsky
State University of New York Health Science Center at Syracuse
Syracuse, New York, 13210
United States
Paul Phillips
Arthritis Associates, LLP
Albany, New York, 12208
United States
Norman Romanoff
Arthritis and Rheumatic Disease Center at Saint Barnabas
Livingston, New Jersey, 07039
United States
Elliot Rosenstein
Jonathan D. Krant MD., FACP
Pittsfield, Massachusetts, 01201
United States
Jonathan Krant
Martin S. Farber
Schenectady, New York,
United States
Martin Farber
Lahey Clinic Department of Rheumatology
Burlington, Massachusetts, 01805
United States
Jonathan Kay
David R. Mandel, MD
Chardon, Ohio, 44024
United States
David Mandel
Bassett Health Care
Cooperstown, New York, 13326
United States
Donald Raddatz
Geisinger Health System
Danville, Pennsylvania, 17822
United States
Eric Newman
UPMC Health System Arthritis and Internal Medicine
Pittsburgh, Pennsylvania, 15213
United States
Terence Starz
Hospital for Joint Diseases Orthopaedic Institute New York Medical Center
New York City, New York,
United States
Steven Abramson
Regional Rheumatology Associates
Binghamton, New York, 13905
United States
Thomas Oven
Arthritis Health Associates, PPLC
Syracuse, New York, 13210
United States
Lorne Runge
Roger Williams Hospital Division of Rheumatology
Providence, Rhode Island, 02908
United States
Edward Lally
UCSD Center for Innovative Therapy
La Jolla, California, 92037
United States
Arthur Kavanaugh
Benaroya Research Institute
Seattle, Washington, 98101
United States
Daniel Furst
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
Alan Kivitz
The Osteoporosis & Clinical Trials Center
Hagerstown, Pennsylvania, 21740
United States
Raymond Malamet
Donald Wexler MD
Schenectady, New York, 12304
United States
Donald Wexler
Additional Information:
Study ID Numbers: R01 AT000309-01A2;
Study Start Date: February 2004
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072982
Other Rheumatoid Arthritis Studies:
1. Efficacy and Safety of Investigational Drug in Patients with Rheumatoid Arthritis Who Failed at Least One DMARD (Disease Modifying Anti-Rheumatic Drug)
2. Safety Study for Remicade
3. Specimen Collection for Individuals with Lung Disease Associated with Rheumatoid Arthritis
4. Identification of Genes Associated with Lung Disease in Patients with Rheumatoid Arthritis
5. Clinically Important Changes in Rheumatoid Arthritis
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
Other Massachusetts Clinical Trials
Other Burlington Clinical Trials
Treatment of Rheumatoid Arthritis with Marine and Botanical Oils
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