Efficacy of Fish Oil in Lupus Patients

September 28, 2016 updated by: Michelle Petri M.D.,MPH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-treatment(baseline) and post-treatment (after 12 weeks)
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.
pre-treatment(baseline) and post-treatment (after 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michelle Petri M.D.,MPH

Investigators

  • Principal Investigator: Michelle A Petri, MD, MPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00023813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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