Efficacy of Fish Oil in Lupus Patients - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00828178

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Omega-3-acid ethyl esters Device: flow-mediated dilation of the brachial artery Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Omega-3-Polyunsaturated Fatty Acids in Subjects With SLE.

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Omacor

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

We will compare omega-3 versus placebo to determine the effect on brachial artery flow dilation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

We will determine the effect of omega-3 versus placebo on disease activity in SLE. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
We will compare omega-3 versus placebo to determine the effect on markers of inflammation: IL-6, ICAM and VCAM. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator fish oil	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
2: Placebo Comparator	Device: flow-mediated dilation of the brachial artery flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks Drug: Placebo fish oil placebo

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828178

Contacts

Contact: Michelle A Petri, MD, MPH	410-955-9114	mpetri@jhmi.edu
Contact: Parastoo Fazeli, MD	410-614-6046	pfazeli1@jhmi.edu

Locations

United States, Maryland
Lupus Center, Johns Hopkins University
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Michelle A Petri, MD, MPH

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University ( Michelle Petri, M.D. MPH )
Study ID Numbers:	NA_00023813
Study First Received:	January 22, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00828178 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

SLE
atherosclerosis
omega-3

Study placed in the following topic categories:

Atherosclerosis
Autoimmune Diseases
Lupus Erythematosus, Systemic

Lupus
Omega 3 Fatty Acid
Connective Tissue Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 10, 2009