Efficacy of Fish Oil in Lupus Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828178
• Other study ID #: NA_00023813
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2009
• Last updated: June 26, 2012
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: June 2012
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Omega-3-acid ethyl esters
Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks

Device:
• flow-mediated dilation of the brachial artery
flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks

Drug:
• Fish oil
3 capsules qd for 12weeks

Locations

Country	Name	City	State
United States	Lupus Center, Johns Hopkins University	Baltimore	Maryland
United States	The Johns Hopkins Lupus Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Michelle Petri M.D.,MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We will compare omega-3 versus placebo to determine the effect on brachial artery flow dilation.		12 weeks	No
Secondary	We will determine the effect of omega-3 versus placebo on disease activity in SLE.		12 weeks	No
Secondary	We will compare omega-3 versus placebo to determine the effect on markers of inflammation: IL-6, ICAM and VCAM.		12 weeks	No