Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis
NCT ID: NCT00399282
Last Updated: 2007-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2006-10-31
2007-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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Omega-3 and Vitamin E supplementation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
16 Years
75 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Principal Investigators
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Reza Rastmanesh, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Nutrition and Food Sciences Technology Institute
Locations
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Rheumatology Research Center (RRC), Tehran University for medical Sciences (TUMS)
Tehran, , Iran
Countries
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Other Identifiers
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NNFTRI-2484
Identifier Type: -
Identifier Source: org_study_id