Efficacy of Fish Oil in Lupus Patients - NCT00828178-21205 (Clinical Trial 265343)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy265343.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21205 |
| Conditions: |
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Systemic Lupus Erythematosus |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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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| Study is available at: |
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Lupus Center, Johns Hopkins University
Baltimore, MD 21205
United States
Primary Contact:
Michelle A Petri, MD, MPH
Email: mpetri@jhmi.edu
Phone: 410-955-9114 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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