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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: September 28, 2016
Last verified: September 2016
  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
Device: flow-mediated dilation of the brachial artery
Other: corn starch
Phase 4

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


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).


Secondary Outcome Measures:
  • Effect of Omega-3 Versus Placebo on Disease Activity in SLE. [ Time Frame: pre-treatment(baseline) and post-treatment (after 12 weeks) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.


Enrollment: 106
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: corn starch
corn starch; flow-mediated dilation of the brachial artery
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

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   (Adult, Senior)
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.
  • Patients who have coronary artery disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Lupus Center, Johns Hopkins University
Baltimore, Maryland, United States, 21205
The Johns Hopkins Lupus Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Michelle Petri M.D.,MPH
Investigators
Principal Investigator: Michelle A Petri, MD, MPH Johns Hopkins University
  More Information

Publications:
Responsible Party: Michelle Petri M.D.,MPH, Principal investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00828178     History of Changes
Other Study ID Numbers: NA_00023813 
Study First Received: January 22, 2009
Results First Received: September 17, 2013
Last Updated: September 28, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
SLE
atherosclerosis
omega-3

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 06, 2016