Systemic Lupus ErythematosusPhase 4NCT00828178
Efficacy of Fish Oil in Lupus Patients
A Phase 4 study testing Omega-3, flow-mediated dilation of the brachial artery and corn starch in people with Systemic Lupus Erythematosus, run by Michelle Petri M.D.,MPH at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Omega-3, flow-mediated dilation of the brachial artery and corn starch
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Feb 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of SLE are eligible.
- Patients must be 18 years of age or older and able to give informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lupus Center, Johns Hopkins University
Baltimore, Maryland, 21205
The Johns Hopkins Lupus Center
Baltimore, Maryland, 21205
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Omega-3, flow-mediated dilation of the brachial artery, corn starch
- Keywords
- SLE, atherosclerosis, omega-3
- Medical subject headings
- Lupus Erythematosus, Systemic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Drug
Also called Lovaza
Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks
flow-mediated dilation of the brachial arteryDevice
flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks
corn starchOther
3 capsules qd for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Omega-3; Device: flow-mediated dilation of the brachial artery |
| corn starch | Placebo comparator | corn starch; flow-mediated dilation of the brachial artery Receives: Device: flow-mediated dilation of the brachial artery; Other: corn starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (2)
Effect of Omega-3 Versus Placebo on Disease Activity in SLE.
The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks).
SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score.
PGA - range 0-3, high score indicates high disease activity.
Measured: pre-treatment(baseline) and post-treatment (after 12 weeks)
Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.
The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.
Measured: pre-treatment(baseline) and post-treatment (after 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Petri M.D.,MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michelle Petri M.D.,MPH, Johns Hopkins University
- Investigators
- Michelle A Petri, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828178
- Sponsor's protocol ID
- NA_00023813
- Status last verified
- Sep 2016
- First submitted
- 22 Jan 2009
- Last updated
- 18 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 9048514Duffy 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.
PubMed 15290734
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.
- ClinicalTrials.gov ID
- NCT00828178
- Acronym / sponsor ID
- NA_00023813
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, atherosclerosis, omega-3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Michelle Petri M.D.,MPHUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Posted 18 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Drug: Omega-3, Device: flow-mediated dilation of the brachial artery3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters); flow-mediated dilation of the brachial artery |
| corn starch | Placebo comparator | Device: flow-mediated dilation of the brachial artery, Other: corn starchcorn starch; flow-mediated dilation of the brachial artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of SLE are eligible.
- Patients must be 18 years of age or older and able to give informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: LovazaOmega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks | Drug | Omega-3 |
| flow-mediated dilation of the brachial arteryflow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks | Device | Omega-3, corn starch |
| corn starch3 capsules qd for 12weeks | Other | corn starch |
Primary outcome
Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.
Time frame: 12 weeks
The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).
2 secondary outcomes
Effect of Omega-3 Versus Placebo on Disease Activity in SLE.
Time frame: pre-treatment(baseline) and post-treatment (after 12 weeks)
Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.
Time frame: pre-treatment(baseline) and post-treatment (after 12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 9048514Manzi 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.
- Results publication: PubMed 15290734Duffy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle A Petri, MD, MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3, flow-mediated dilation of the brachial artery and corn starch in people with Systemic Lupus Erythematosus, run by Michelle Petri M.D.,MPH at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828178, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.