Clinical trial NCT00072982: Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
Official title: Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Fish oil
Borage oil
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-11-17
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: See Brief Summary

Eligibility 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

Primary outcomes:
measure: The modified Disease Activity Score (DAS28) will be the primary outcome measure.
timeFrame: Assessed every 3 months
Secondary outcomes:
measure: Reduction of other medication for RA
timeFrame: Assessed every 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Arthritis Clinical Intervention Program
state: Alabama
city: Trumbull
country: United States
facility: New England Res. Associates
state: Connecticut
city: Boca Raton
country: United States
facility: RASF Clinical Research Center
state: Florida
city: Tavares
country: United States
facility: Lake Rheumatology
state: Florida
city: Worcester
country: United States
facility: Fallon Clinic Health Care
state: Massachusetts
city: Worcester
country: United States
facility: Division of Rheumatology, Umass Memorial Health Care
state: Massachusetts
city: St. Louis
country: United States
facility: Rheumatology and Internal Medicine Associates of West County, PC
state: Missouri
city: Albany
country: United States
facility: Joel M. Kremer
state: New York
city: Niagara Falls
country: United States
facility: Prem Tambar, MD
state: New York
city: Bryn Mawr
country: United States
facility: Bryn Mawr Medical Specialists
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic
state: South Carolina
Study officials:
affiliation: University of Massachusetts, Worcester
name: Robert B Zurier, MD
role: PRINCIPAL_INVESTIGATOR
References: