Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Phase 3

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: borage seed oil; Drug: combination fish oil and borage seed oil; Drug: fish oil

• Registration Number: NCT00072982
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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

Study Timeline

• Study First Submitted: 2003-11-13
• Study First Submitted QC: 2003-11-14
• Study First Posted: 2003-11-17
• Study Start: 2006-11
• Primary Completion: 2008-05
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-22
• Last Update Posted: 2008-08-25
• Study Completion: 2008-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	borage seed oil	Borage Oil
3	combination fish oil and borage seed oil	Fish Oil and Borage Oil
1	fish oil	Fish Oil

Primary Outcome Measures

Name	Time	Method
The modified Disease Activity Score (DAS28) will be the primary outcome measure.	Assessed every 3 months

Secondary Outcome Measures

Name	Time	Method
Reduction of other medication for RA	Assessed every 3 months

Trial Locations

Locations (13)

Rheumatology and Internal Medicine Associates of West County, PC; 🇺🇸 St. Louis, Missouri, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

UAB Arthritis Clinical Intervention Program; 🇺🇸 Birmingham, Alabama, United States

RASF Clinical Research Center; 🇺🇸 Boca Raton, Florida, United States

Lake Rheumatology; 🇺🇸 Tavares, Florida, United States

Division of Rheumatology, Umass Memorial Health Care; 🇺🇸 Worcester, Massachusetts, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Piedmont Arthritis Clinic; 🇺🇸 Greenville, South Carolina, United States

Prem Tambar, MD; 🇺🇸 Niagara Falls, New York, United States

Joel M. Kremer; 🇺🇸 Albany, New York, United States

Fallon Clinic Health Care; 🇺🇸 Worcester, Massachusetts, United States

Bryn Mawr Medical Specialists; 🇺🇸 Bryn Mawr, Pennsylvania, United States

New England Res. Associates; 🇺🇸 Trumbull, Connecticut, United States