Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Fish Oil in Lupus Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Petri M.D.,MPH, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00828178
First received: January 22, 2009
Last updated: June 26, 2012
Last verified: June 2012

January 22, 2009
June 26, 2012
February 2009
February 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00828178 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Fish Oil in Lupus Patients
A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: Omega-3-acid ethyl esters
    Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks
    Other Name: Lovaza
  • 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
  • Active Comparator: 1
    fish oil
    Interventions:
    • Drug: Omega-3-acid ethyl esters
    • Device: flow-mediated dilation of the brachial artery
  • Placebo Comparator: 2
    Interventions:
    • Device: flow-mediated dilation of the brachial artery
    • Drug: Fish oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828178
NA_00023813
Yes
Michelle Petri M.D.,MPH, Johns Hopkins University
Michelle Petri M.D.,MPH
Not Provided
Principal Investigator: Michelle A Petri, MD, MPH Johns Hopkins University
Johns Hopkins University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP