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

NCT02021513 | Completed Phase 2

• 1 other identifier: EO3SLE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Fish Oil; Omega-3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Disease Activity

  Change from baseline at 6 months

• SF-36

  Change from baseline at 6 months

• FSS

  Change from baseline at 6 months

Study Arms (2)

Fish Oil

EXPERIMENTAL

Fish Oil (2.25gm EPA and 2.25gm DHA total)

Dietary Supplement: Fish Oil

Placebo

PLACEBO COMPARATOR

Olive Oil

Dietary Supplement: Olive Oil

Interventions

Fish Oil DIETARY_SUPPLEMENT

Fish Oil (2.25gm EPA and 2.25gm DHA total)

Also known as: Omega-3 Fatty Acids, DHA/EPA

Fish Oil

Olive Oil DIETARY_SUPPLEMENT

Placebo group

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 26283629 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Fish Oils; Fatty Acids, Omega-3; Olive Oil

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Cristina G Arriens, MD

  University of Texas Southwestern Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctural Fellow Clinical Research

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 27, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 27, 2013

Record last verified: 2013-12

Locations

US (1)