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

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ClinicalTrials.gov Identifier: NCT02021513
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Cristina Gale Arriens, University of Texas Southwestern Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Dietary Supplement: Fish Oil Dietary Supplement: Olive Oil Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fish Oil
Fish Oil (2.25gm EPA and 2.25gm DHA total)
 Dietary Supplement: Fish Oil
Fish Oil (2.25gm EPA and 2.25gm DHA total)
Other Names:
  • Omega-3 Fatty Acids
  • DHA/EPA
Placebo Comparator: Placebo
Olive Oil
 Dietary Supplement: Olive Oil
Placebo group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021513


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Chair: Cristina G Arriens, MD UT Southwestern Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cristina Gale Arriens, Postdoctural Fellow Clinical Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02021513     History of Changes
Other Study ID Numbers: EO3SLE
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: December 2013

Keywords provided by Cristina Gale Arriens, University of Texas Southwestern Medical Center:
SLE
Fish Oil
Omega-3

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