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Efficacy of Fish Oil in Lupus Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Johns Hopkins University.   Recruitment status was  Active, not recruiting

First Received on January 22, 2009.   Last Updated on May 25, 2010   History of Changes
Sponsor: Johns Hopkins University
Information provided by: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00828178
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
 Drug: Omega-3-acid ethyl esters
Device: flow-mediated dilation of the brachial artery
Drug: Fish oil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.

Resource links provided by NLM:

MedlinePlus related topics: Lupus
Drug Information available for: Omega-3-acid Ethyl Esters Lovaza
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • We will compare omega-3 versus placebo to determine the effect on brachial artery flow dilation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We will determine the effect of omega-3 versus placebo on disease activity in SLE. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • We will compare omega-3 versus placebo to determine the effect on markers of inflammation: IL-6, ICAM and VCAM. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
fish oil
 Drug: Omega-3-acid ethyl esters
Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks
Other Name: Lovaza
Device: flow-mediated dilation of the brachial artery
flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks
Placebo Comparator: 2 Device: flow-mediated dilation of the brachial artery
flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks
Drug: Fish oil
3 capsules qd for 12weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828178

Locations
United States, Maryland
Lupus Center, Johns Hopkins University
Baltimore, Maryland, United States, 21205
The Johns Hopkins Lupus Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Michelle A Petri, MD, MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Michelle Petri, M.D. MPH, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00828178     History of Changes
Other Study ID Numbers: NA_00023813
Study First Received: January 22, 2009
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
SLE
atherosclerosis
omega-3

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2012



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