Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Fish Oil, Omega-3
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.
Interventions
DIETARY_SUPPLEMENTFish Oil
Fish Oil (2.25gm EPA and 2.25gm DHA total)
DIETARY_SUPPLEMENTOlive Oil
Placebo group
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity | Change from baseline at 6 months | SELENA-SLEDAI |
| SF-36 | Change from baseline at 6 months | RAND Short Form 36 Quality of Life Assessment |
| FSS | Change from baseline at 6 months | Fatigue Severity Scale |
Countries
United States
Outcome results
None listed