Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399282
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2006-11-13
Brief Title:
Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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
Comparisons Comparison of groups supplemented with omega-3 omega-3 with Vit E and placebo Medium chain triglycerides MCT
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
Comparisons Comparison of groups supplemented with omega-3 omega-3 with Vit E and placebo Medium chain triglycerides MCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None