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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Dietary supplement: Fish Oil; Dietary supplement: Olive Oil

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolomic profile	Blood collection by venipuncture for serum assessment of metabolomic profile (fatty acids, markers of oxidative stress, markers of inflammation, markers of energy stores).	Change from baseline at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity	SELENA-SLEDAI	Change from baseline at 6 months
SF-36	RAND Short Form 36 Quality of Life Assessment	Change from baseline at 6 months
FSS	Fatigue Severity Scale	Change from baseline at 6 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Study Chair: Cristina G Arriens, MD, UT Southwestern Medical Center

Publications and helpful links

General Publications

• Arriens C, Hynan LS, Lerman RH, Karp DR, Mohan C. Placebo-controlled randomized clinical trial of fish oil's impact on fatigue, quality of life, and disease activity in Systemic Lupus Erythematosus. Nutr J. 2015 Aug 18;14:82. doi: 10.1186/s12937-015-0068-2.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 13, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Estimate): December 27, 2013
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: SLE; Fish Oil; Omega-3
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: EO3SLE