Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Study Overview
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Brief Summary
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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
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See Brief Summary

Official Title
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Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: fish oil
* Drug: borage seed oil
* Drug: combination fish oil and borage seed oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Fish Oil | Drug: fish oil<br>* 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.<br>* Other names: EPA;|
| Active Comparator: 2<br>Borage Oil | Drug: borage seed oil<br>* Borage oil 13 capsules divided doses daily for 18 months<br>* Other names: GLA;|
| Active Comparator: 3<br>Fish Oil and Borage Oil | Drug: combination fish oil and borage seed oil<br>* Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months<br>* Other names: EPA and GLA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Disease Activity Score (DAS28) will be the primary outcome measure. |  | Assessed every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of other medication for RA |  | Assessed every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish oil, Borage oil