Efficacy of Fish Oil in Lupus Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Omega-3
* Device: flow-mediated dilation of the brachial artery
* Other: corn starch


Participation Criteria
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Eligibility 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. Patients who have coronary artery disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3<br>3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters); flow-mediated dilation of the brachial artery | Drug: Omega-3<br>* Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks<br>* Other names: Lovaza;Device: flow-mediated dilation of the brachial artery<br>* flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks<br>|
| Placebo Comparator: corn starch<br>corn starch; flow-mediated dilation of the brachial artery | Device: flow-mediated dilation of the brachial artery<br>* flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks<br>Other: corn starch<br>* 3 capsules qd for 12weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. | The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Omega-3 Versus Placebo on Disease Activity in SLE. | The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks). SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score. PGA - range 0-3, high score indicates high disease activity. | pre-treatment(baseline) and post-treatment (after 12 weeks) | 
| Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo. | The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported. | pre-treatment(baseline) and post-treatment (after 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerosis, omega-3, SLE