Efficacy of Fish Oil in Lupus Patients

Michelle Petri M.D.,MPH

Status and phase: Completed; Phase 4

Conditions: Systemic Lupus Erythematosus

Treatments: Other: corn starch; Device: flow-mediated dilation of the brachial artery; Drug: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT00828178

NA_00023813

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

Omega-3

Active Comparator group

Description:

3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters); flow-mediated dilation of the brachial artery

Treatment:

Drug: Omega-3

Device: flow-mediated dilation of the brachial artery

corn starch

Placebo Comparator group

Description:

corn starch; flow-mediated dilation of the brachial artery

Treatment:

Other: corn starch

Device: flow-mediated dilation of the brachial artery