Efficacy of Fish Oil in Lupus Patients

• Sponsor: Michelle Petri M.D.,MPH (Other)
• Overall Status: Completed
• CT.gov ID: NCT00828178
• Collaborator: (none)
• Enrollment: 106
• Locations: 2
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 53
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Omega-3; Device: flow-mediated dilation of the brachial artery; Other: corn starch	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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.
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Omega-3; Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks; Other Names: 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: corn starch corn starch; flow-mediated dilation of the brachial artery	Device: flow-mediated dilation of the brachial artery; flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks; Other: corn starch; 3 capsules qd for 12weeks

Outcome Measures

Primary Outcome Measures

1. Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. [12 weeks]

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

Secondary Outcome Measures

1. Effect of Omega-3 Versus Placebo on Disease Activity in SLE. [pre-treatment(baseline) and post-treatment (after 12 weeks)]

   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.

2. Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo. [pre-treatment(baseline) and post-treatment (after 12 weeks)]

   The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Lupus Center, Johns Hopkins University	Baltimore	Maryland	United States	21205
2	The Johns Hopkins Lupus Center	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Michelle Petri M.D.,MPH

Investigators

• Principal Investigator: Michelle A Petri, MD, MPH, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michelle Petri M.D.,MPH, Principal investigator, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00828178
• Other Study ID Numbers: NA_00023813
• First Posted: Jan 23, 2009
• Last Update Posted: Nov 18, 2016
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Michelle Petri M.D.,MPH, Principal investigator, Johns Hopkins University: SLE; atherosclerosis; omega-3
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

Participant Flow

Recruitment Details	106 patients were consented and 87 were randomized. Patients were part of the Hopkins Lupus Cohort seen quarterly.
Pre-assignment Detail	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.

Arm/Group Title	Fish Oil	Placebo
Arm/Group Description	fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily	Placebo (corn starch) once daily
Period Title: Overall Study
STARTED	42	45
COMPLETED	42	43
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Fish Oil	Placebo	Total
Arm/Group Description	3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	corn starch	Total of all reporting groups
Overall Participants	42	45	87
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	42 100%	45 100%	87 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.9 (10.6)	45.5 (10.8)	47.2 (10.4)
Sex: Female, Male (Count of Participants)
Female	41 97.6%	39 86.7%	80 92%
Male	1 2.4%	6 13.3%	7 8%
Region of Enrollment (participants) [Number]
United States	42 100%	45 100%	87 100%

Outcome Measures

1. Primary Outcome

Title	Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.
Description	The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Patients who successfully completed the trial.

Arm/Group Title	Omega-3	Placebo
Arm/Group Description	3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	Corn starch
Measure Participants	42	43
Post-treatment baseline diameter	0.32 (0.04)	0.33 (0.06)
Pre-treatment baseline diameter	0.32 (0.06)	0.33 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3, Placebo
	Comments	Statistical analysis system (SAS) software was used (SAS Institute Inc. Cary, North Carolina, SAS 9.2). Baseline demographic and clinical characteristics were summarized using appropriate descriptive statistics and compared across treatment groups using Chi-square. Two-sample t tests were used in the statistical analysis of the FMD outcomes. ANCOVA was used to compare the groups with respect to changes in clinical variables adjusting for baseline values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Effect of Omega-3 Versus Placebo on Disease Activity in SLE.
Description	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.
Time Frame	pre-treatment(baseline) and post-treatment (after 12 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3	Placebo
Arm/Group Description	3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	Placebo (cornstarch)
Measure Participants	42	43
SELENA-SLEDAI	1.5 (2)	1.5 (2.5)
PGA	0.49 (0.52)	0.41 (0.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1801
	Comments	This Statistical Analysis applies category SELENA-SLEDAI
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.
Description	The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.
Time Frame	pre-treatment(baseline) and post-treatment (after 12 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3	Placebo
Arm/Group Description	3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	Corn Starch
Measure Participants	42	43
sICAM-1	-1.61 (40.27)	-5.56 (48.74)
sVCAM-1	-17.52 (101.65)	26.57 (135.98)

Adverse Events

Arm/Group Title	Omega-3		Placebo
Arm/Group Description	3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)		Placebo (cornstarch)
All Cause Mortality
	Omega-3		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omega-3		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Omega-3		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.