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Sponsored by: |
Shaheed Beheshti Medical University |
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Information provided by: | Shaheed Beheshti Medical University |
ClinicalTrials.gov Identifier: | NCT00399282 |
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.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Omega-3 and Vitamin E supplementation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis |
Estimated Enrollment: | 75 |
Study Start Date: | October 2006 |
Study Completion Date: | April 2007 |
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).
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Rheumatology Research Center (RRC), Tehran University for medical Sciences (TUMS) | |
Tehran, Iran, Islamic Republic of |
Principal Investigator: | Reza Rastmanesh, Ph.D. | National Nutrition and Food Sciences Technology Institute |
Study ID Numbers: | NNFTRI-2484 |
Study First Received: | November 13, 2006 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00399282 History of Changes |
Health Authority: | Iran: Ministry of Health |
Rheumatoid arthritis Health related quality of life Omega 3 fatty acids Vitamin E |
Tocopherol acetate Antioxidants Autoimmune Diseases Joint Diseases Arthritis, Rheumatoid Quality of Life Trace Elements Rheumatic Diseases Alpha-Tocopherol |
Tocopherols Vitamin E Musculoskeletal Diseases Arthritis Vitamins Connective Tissue Diseases Tocotrienols Micronutrients |
Tocopherol acetate Antioxidants Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Growth Substances Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid Rheumatic Diseases Protective Agents |
Pharmacologic Actions Alpha-Tocopherol Tocopherols Vitamin E Musculoskeletal Diseases Vitamins Arthritis Connective Tissue Diseases Tocotrienols Micronutrients |