Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus

Last updated: December 19, 2013
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

2

Condition

Lupus

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

N/A

Clinical Study ID

NCT02021513
EO3SLE
  • Ages 18-64
  • All Genders

Study Summary

This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus and lupus nephritis patients. We propose to recruit and consent SLE patients who will be randomized to either receive the study drug, an over the counter fish oil supplement, or a placebo that contains olive oil. They will have a baseline metabolomic profile (blood test), nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI lupus disease activity assessments completed at the time of study medication distribution. Once 6 months of either the study drug or placebo is completed, then pill counts, assessments of experience/adherence (including side-effects, adverse effects, complaints, and un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and metabolomic profile will be assessed. The study duration for each patient will be 6 months from initiation of the study drug. It is hypothesized that patients receiving the fish oil supplement will have improvement in their metabolomic profile. Additionally it is hypothesized that patients receiving the fish oil supplement will have improvement in disease activity, fatigue, and quality of life assessments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female

  • All ethnic groups

  • Aged 18-64

  • Biopsy proven diagnosis of Lupus Nephritis and/or fulfillment of 4 or more AmericanCollege of Rheumatology criteria for the diagnosis of Systemic Lupus Erythematosus

Exclusion

Exclusion Criteria:

  • Currently taking, or have taken in the last 2 months, fish oil/omega-3 fattyacid/DHA/EPA

  • Allergic to fish oil, shellfish, or other fish products

  • Pregnant

  • Currently taking the medication: Tositumomab (Bexxar)

  • Currently taking anti-coagulant medications (Abciximab, Acenocoumarol, Anisindione,Ardeparin, Argatroban, Bivalirudin, Certoparin, Cilostazol, Clopidogrel, Dalteparin,Danaparoid, Defibrotide, Dermatan Sulfate, Desirudin, Dicumarol, Enoxaparin,Eptifibatide, Fondaparinux, Heparin, Lamifiban, Nadroparin, Phenindione,Phenprocoumon, Reviparin, Sibrafiban, Tinzaparin,Tirofiban, Warfarin, Xemilofiban)

Study Design

Total Participants: 50
Study Start date:
January 01, 2012
Estimated Completion Date:
June 30, 2013

Study Description

Supplementation with EPA and DHA could potentially reduce the inflammatory state of SLE patients. This study is a single blind placebo-controlled pilot for SLE patients with 25 scheduled to receive omega-3 (EPA 2.25g/DHA 2.25g) daily and 25 scheduled to receive placebo (olive oil), for 6 months. Pre and post supplementation assessments will be made to determine if EPA and DHA levels increase, and if the levels of lipid peroxidation products, other cellular energy intermediates, and inflammatory markers are affected by EPA/DHA. Additionally, lupus disease activity, fatigue, quality of life, and diet will be assessed to determine if these parameters are related to the metabolome in SLE.

  • Aim 1:

    • To determine if the metabolomic disturbances of lupus patients improve following supplementation with omega-3 fatty acids.
  • Aim 2:

    • To determine if lupus disease activity, fatigue, and quality of life improve and are related to the metabolomic profile changes.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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