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Efficacy of Fish Oil in Lupus Patients - NCT00828178-21205(Clinical Trial 265343)



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City:  Baltimore
State:  
MD
Zip Code: 21205
Conditions: Systemic Lupus Erythematosus
Purpose: The investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil will improve disease activity and endothelial function in Systemic Lupus Erythematosus (SLE) patients.
Study summary: Patients with SLE have a fifty-fold increased risk of myocardial infarction. This risk is not totally explained by traditional cardiovascular risk factors. In a previous double-blind study of atorvastatin in SLE, there was no reduction in surrogate measures of coronary artery disease (coronary calcium, coronary IMT, carotid plaque) and no effect on inflammatory markers such as ICAM, VCAM, IL-6 and CRP. We need to find novel approaches to reduce coronary artery disease in SLE. In a preliminary study, omega-3 was shown to improve flow mediated dilation of the brachial artery, oxidative stress and disease activity in lupus patients. In this study we will determine if omega-3 improves brachial artery flow dilation, disease activity and other vascular inflammatory markers (IL-6, s-VCAM-1, s-ICAM-1) in SLE, in a double-blind placebo-controlled trial.
Criteria: Inclusion Criteria: - Patients with a clinical diagnosis of SLE are eligible. - Patients must be 18 years of age or older and able to give informed consent. Exclusion Criteria: - SLE patients who are allergic to fish oil or any omega 3 product. - Patients who are pregnant or are planning to become pregnant or are nursing. - Omega-3 use within the previous 6 weeks of enrollment. - Use of warfarin or heparin.
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Data Source: ClinicalTrials.gov
Date Processed: May 21, 2010
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