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Completed

NCT Number: NCT02021513

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or Female
  • All ethnic groups
  • Aged 18-64
  • Biopsy proven diagnosis of Lupus Nephritis and/or fulfillment of 4 or more American College of Rheumatology criteria for the diagnosis of Systemic Lupus Erythematosus

Exclusion criteria

  • Currently taking, or have taken in the last 2 months, fish oil/omega-3 fatty acid/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)

Treatment and study plan

Fish Oil

Dietary Supplement

Fish Oil (2.25gm EPA and 2.25gm DHA total)

Other names: Omega-3 Fatty Acids, DHA/EPA

Olive Oil

Dietary Supplement

Placebo group

Primary outcomes

  1. Metabolomic profile

    Time frame: Change from baseline at 6 months

    Blood collection by venipuncture for serum assessment of metabolomic profile (fatty acids, markers of oxidative stress, markers of inflammation, markers of energy stores).

Secondary outcomes

  1. Disease Activity

    Time frame: Change from baseline at 6 months

    SELENA-SLEDAI

  2. SF-36

    Time frame: Change from baseline at 6 months

    RAND Short Form 36 Quality of Life Assessment

  3. FSS

    Time frame: Change from baseline at 6 months

    Fatigue Severity Scale

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 27, 2013
Registry last updated
Dec 27, 2013

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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