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Efficacy of Fish Oil in Lupus Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828178
First Posted: January 23, 2009
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michelle Petri M.D.,MPH, Johns Hopkins University
January 22, 2009
January 23, 2009
September 17, 2013
November 18, 2016
November 18, 2016
February 2009
February 2011   (Final data collection date for primary outcome measure)
Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. [ Time Frame: 12 weeks ]
The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).
We will compare omega-3 versus placebo to determine the effect on brachial artery flow dilation. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00828178 on ClinicalTrials.gov Archive Site
  • Effect of Omega-3 Versus Placebo on Disease Activity in SLE. [ Time Frame: pre-treatment(baseline) and post-treatment (after 12 weeks) ]

    The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks).

    SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score.

    PGA - range 0-3, high score indicates high disease activity.

  • Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo. [ Time Frame: pre-treatment(baseline) and post-treatment (after 12 weeks) ]
    The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.
  • We will determine the effect of omega-3 versus placebo on disease activity in SLE. [ Time Frame: 12 weeks ]
  • We will compare omega-3 versus placebo to determine the effect on markers of inflammation: IL-6, ICAM and VCAM. [ Time Frame: 12 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: Omega-3
    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
  • Other: corn starch
    3 capsules qd for 12weeks
  • Active Comparator: Omega-3
    3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters); flow-mediated dilation of the brachial artery
    Interventions:
    • Drug: Omega-3
    • Device: flow-mediated dilation of the brachial artery
  • Placebo Comparator: corn starch
    corn starch; flow-mediated dilation of the brachial artery
    Interventions:
    • Device: flow-mediated dilation of the brachial artery
    • Other: corn starch

*   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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00828178
NA_00023813
Yes
Not Provided
Plan to Share IPD: No
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
September 2016

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