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Efficacy of Fish Oil in Lupus Patients

NCT ID: NCT00828178

Last Updated: 2016-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Patients with SLE have a fifty-fold increased risk of myocardial infarction. This risk is not totally explained by traditional cardiovascular risk factors. In a previous double-blind study of atorvastatin in SLE, there was no reduction in surrogate measures of coronary artery disease (coronary calcium, coronary IMT, carotid plaque) and no effect on inflammatory markers such as ICAM, VCAM, IL-6 and CRP. We need to find novel approaches to reduce coronary artery disease in SLE. In a preliminary study, omega-3 was shown to improve flow mediated dilation of the brachial artery, oxidative stress and disease activity in lupus patients. In this study we will determine if omega-3 improves brachial artery flow dilation, disease activity and other vascular inflammatory markers (IL-6, s-VCAM-1, s-ICAM-1) in SLE, in a double-blind placebo-controlled trial.

Conditions

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Systemic Lupus Erythematosus

Keywords

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SLE atherosclerosis omega-3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3

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

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DRUG

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

flow-mediated dilation of the brachial artery

Intervention Type DEVICE

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

corn starch

corn starch; flow-mediated dilation of the brachial artery

Group Type PLACEBO_COMPARATOR

flow-mediated dilation of the brachial artery

Intervention Type DEVICE

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

corn starch

Intervention Type OTHER

3 capsules qd for 12weeks

Interventions

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Omega-3

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

Intervention Type DRUG

flow-mediated dilation of the brachial artery

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

Intervention Type DEVICE

corn starch

3 capsules qd for 12weeks

Intervention Type OTHER

Other Intervention Names

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Lovaza

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michelle Petri M.D.,MPH

OTHER

Sponsor Role lead

Responsible Party

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Michelle Petri M.D.,MPH

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michelle A Petri, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Lupus Center, Johns Hopkins University

Baltimore, Maryland, United States

Site Status

The Johns Hopkins Lupus Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 9048514 (View on PubMed)

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.

Reference Type RESULT
PMID: 15290734 (View on PubMed)

Other Identifiers

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NA_00023813

Identifier Type: -

Identifier Source: org_study_id