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

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Dietary Supplement: Fish Oil; Dietary Supplement: Olive Oil

• Registration Number: NCT02021513
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-27
• Last Update Posted: 2013-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish Oil	Fish Oil	Fish Oil (2.25gm EPA and 2.25gm DHA total)
Placebo	Olive Oil	Olive Oil

Primary Outcome Measures

Name	Time	Method
Metabolomic profile	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

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

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States