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Completed

NCT Number: NCT00828178

Efficacy of Fish Oil in Lupus Patients

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.

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Key information

Conditions

Systemic Lupus Erythematosus Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3

Drug

Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks

Other names: Lovaza

flow-mediated dilation of the brachial artery

Device

flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks

corn starch

Other

3 capsules qd for 12weeks

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Michelle Petri M.D.,MPH

Other

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 23, 2009
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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