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
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Condition or disease | Intervention/treatment | Phase |
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Systemic Lupus Erythematosus | Dietary Supplement: Fish Oil Dietary Supplement: Olive Oil | Phase 2 |
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.
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Aim 1:
- To determine if the metabolomic disturbances of lupus patients improve following supplementation with omega-3 fatty acids.
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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 (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 |

Arm | Intervention/treatment |
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Experimental: Fish Oil
Fish Oil (2.25gm EPA and 2.25gm DHA total)
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Dietary Supplement: Fish Oil
Fish Oil (2.25gm EPA and 2.25gm DHA total)
Other Names:
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Placebo Comparator: Placebo
Olive Oil
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Dietary Supplement: Olive Oil
Placebo group |
- 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).
- Disease Activity [ Time Frame: Change from baseline at 6 months ]SELENA-SLEDAI
- SF-36 [ Time Frame: Change from baseline at 6 months ]RAND Short Form 36 Quality of Life Assessment
- FSS [ Time Frame: Change from baseline at 6 months ]Fatigue Severity Scale

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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)

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
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Study Chair: | Cristina G Arriens, MD | UT Southwestern Medical Center |
Responsible Party: | Cristina Gale Arriens, Postdoctural Fellow Clinical Research, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT02021513 |
Other Study ID Numbers: |
EO3SLE |
First Posted: | December 27, 2013 Key Record Dates |
Last Update Posted: | December 27, 2013 |
Last Verified: | December 2013 |
SLE Fish Oil Omega-3 |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |