Clinical trial NCT00828178: Efficacy of Fish Oil in Lupus Patients
Official title: A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
atherosclerosis
omega-3
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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.
* Patients who have coronary artery disease.

Primary outcomes:
measure: Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of Omega-3 Versus Placebo on Disease Activity in SLE.
timeFrame: pre-treatment(baseline) and post-treatment (after 12 weeks)
measure: Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.
timeFrame: pre-treatment(baseline) and post-treatment (after 12 weeks)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Lupus Center, Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins Lupus Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michelle A Petri, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manzi S, Meilahn EN, Rairie JE, Conte CG, Medsger TA Jr, Jansen-McWilliams L, D'Agostino RB, Kuller LH. Age-specific incidence rates of myocardial infarction and angina in women with systemic lupus erythematosus: comparison with the Framingham Study. Am J Epidemiol. 1997 Mar 1;145(5):408-15. doi: 10.1093/oxfordjournals.aje.a009122.
citation: Duffy EM, Meenagh GK, McMillan SA, Strain JJ, Hannigan BM, Bell AL. The clinical effect of dietary supplementation with omega-3 fish oils and/or copper in systemic lupus erythematosus. J Rheumatol. 2004 Aug;31(8):1551-6.