Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.

Detailed Description
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The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis. Most of studies on omega-3 fatty acids (omega-3) supplementation in patients with rheumatoid arthritis (RA) have clearly shown potentially beneficial changes in cytokine and eicosanoid metabolism. The overall clinical improvement, however, has been only moderate. One explanation is that an increased intake of omega-3 leads to a reduction in the availability of antioxidants and an increased generation of lipid peroxides. The majority of the anti-inflammatory drugs routinely used nowadays are COX (cyclo-oxygenase) inhibitors. Mechanism of COX II inhibitors is similar of omega-3. So, it is difficult to differentiate omega-3 net effects in some situations. Existing clinical trials on omega-3 and vitamin E (Vit E) are sometimes questioned due to using omega-6 fatty acids as placebo and neglecting omega-6 fatty acid intake in the diet. A comprehensive randomized controlled double-blind trial would have omega-6 fatty acids served as placebo in patients who are well matched in terms of therapies and drugs. Comparison(s): Comparison of groups supplemented with omega-3, omega-3 with Vit E, and placebo (Medium chain triglycerides: MCT).

Official Title
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Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Omega-3 and Vitamin E supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of rheumatoid arthritis according American college of rheumatology (ACR) Exclusion Criteria: Infection Major joint malformations Simultaneous diseases like metabolic and gastrointestinal Being class IV according to ACR Drug dose fluctuations History of Vit E and/or omega-3 supplements during past six months Gastric irrigations

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omega-3 and Vitamin E supplementation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks |  |  | 
| Disease activity score at 0, 6 and 12 weeks |  |  | 
| Duration of morning stiffness (in minutes) at 0, 6 and 12 weeks |  |  | 
| Joint pain intensity, on a five-point scale (0, absent) at 0, 6 and 12 weeks |  |  | 
| Onset of fatigue (in minutes) after walking at 0, 6 and 12 weeks |  |  | 
| Ritchie's articular index for pain joints at 0, 6 and 12 weeks |  |  | 
| Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at 0, 6 and 12 weeks |  |  | 
| Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at 0, 6 and 12 weeks |  |  | 
| Classification of functional status in RA according to revised criteria of the American |  |  | 
| College of Rheumatology at 0, 6 and 12 weeks |  |  | 
| Patient's satisfaction in activities of daily living based on a Persian version of Health Assessment Questionnaire (PE-HAQ) at 0, 6 and 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha at 0, 6 and 12 weeks |  |  | 
| IL-1 beta at 0, 6 and 12 weeks |  |  | 
| C-reactive protein at 0, 6 and 12 weeks |  |  | 
| Erythrocyte sedimentation rate at 0, 6 and 12 weeks |  |  | 
| Malondialdehyde at 0, 6 and 12 weeks |  |  | 
| Systolic blood pressure at 0, 6 and 12 weeks |  |  | 
| Diastolic blood pressure at 0, 6 and 12 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Health related quality of life, Omega 3 fatty acids, Vitamin E