NCT00828178

Brief Summary

The investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil will improve disease activity and endothelial function in Systemic Lupus Erythematosus (SLE) patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

November 18, 2016

Completed
Last Updated

November 18, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

January 22, 2009

Results QC Date

September 17, 2013

Last Update Submit

September 28, 2016

Conditions

Systemic Lupus Erythematosus

Keywords

SLEatherosclerosisomega-3

Outcome Measures

Primary Outcomes (1)

  • Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.

    The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).

    12 weeks

Secondary Outcomes (2)

  • Effect of Omega-3 Versus Placebo on Disease Activity in SLE.

    pre-treatment(baseline) and post-treatment (after 12 weeks)

  • Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.

    pre-treatment(baseline) and post-treatment (after 12 weeks)

Study Arms (2)

Omega-3

ACTIVE COMPARATOR

3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters); flow-mediated dilation of the brachial artery

Drug: Omega-3Device: flow-mediated dilation of the brachial artery

corn starch

PLACEBO COMPARATOR

corn starch; flow-mediated dilation of the brachial artery

Device: flow-mediated dilation of the brachial arteryOther: corn starch

Interventions

Omega-3DRUG

Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks

Also known as: Lovaza
Omega-3
flow-mediated dilation of the brachial arteryDEVICE

flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks

Omega-3corn starch
corn starchOTHER

3 capsules qd for 12weeks

corn starch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a clinical diagnosis of SLE are eligible.
  • Patients must be 18 years of age or older and able to give informed consent.

You may not qualify if:

  • SLE patients who are allergic to fish oil or any omega 3 product.
  • Patients who are pregnant or are planning to become pregnant or are nursing.
  • Omega-3 use within the previous 6 weeks of enrollment.
  • Use of warfarin or heparin.
  • Patients who have coronary artery disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lupus Center, Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

The Johns Hopkins Lupus Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • Manzi S, Meilahn EN, Rairie JE, Conte CG, Medsger TA Jr, Jansen-McWilliams L, D'Agostino RB, Kuller LH. Age-specific incidence rates of myocardial infarction and angina in women with systemic lupus erythematosus: comparison with the Framingham Study. Am J Epidemiol. 1997 Mar 1;145(5):408-15. doi: 10.1093/oxfordjournals.aje.a009122.

    PMID: 9048514RESULT

  • Duffy EM, Meenagh GK, McMillan SA, Strain JJ, Hannigan BM, Bell AL. The clinical effect of dietary supplementation with omega-3 fish oils and/or copper in systemic lupus erythematosus. J Rheumatol. 2004 Aug;31(8):1551-6.

    PMID: 15290734RESULT

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAtherosclerosis

Interventions

Docosahexaenoic AcidsOmacorStarch

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Results Point of Contact

Title
Dr. Michelle Petri
Organization
Johns Hopkins University School of Medicine
mpetri@jhmi.edu
410-955-9114

Study Officials

  • Michelle A Petri, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 18, 2016

Results First Posted

November 18, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)