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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| corn starch | Placebo Comparator | corn starch; flow-mediated dilation of the brachial artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Drug | Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle A Petri, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lupus Center, Johns Hopkins University | Baltimore | Maryland | 21205 | United States | ||
| The Johns Hopkins Lupus Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9048514 | Result | 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. | |
| 15290734 |
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Some of patients were excluded before being randomized for several reasons including "change of mind by patient, became pregnant, diagnosed with breast ca". Therefore a total of 87 patients started the trial.
106 patients were consented and 87 were randomized. Patients were part of the Hopkins Lupus Cohort seen quarterly.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fish Oil | fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily |
| FG001 | Placebo | Placebo (corn starch) once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fish Oil | 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) |
| BG001 | Placebo | corn starch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Patients who successfully completed the trial. | Posted | Mean | Standard Deviation | cm | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 | 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Petri | Johns Hopkins University School of Medicine | 410-955-9114 | mpetri@jhmi.edu |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| C405603 | Omacor |
| D013213 | Starch |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| flow-mediated dilation of the brachial artery | Device | flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks |
|
| corn starch | Other | 3 capsules qd for 12weeks |
|
| 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. | pre-treatment(baseline) and post-treatment (after 12 weeks) |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | pre-treatment(baseline) and post-treatment (after 12 weeks) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | pre-treatment(baseline) and post-treatment (after 12 weeks) |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Placebo | Placebo (cornstarch) | 0 | 43 | 0 | 43 |
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| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |