At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 106 enrolled
Drug / intervention
Omega-3 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.
In Brief
A Phase 4 clinical trial evaluating Omega-3, flow-mediated dilation of the brachial artery, and 1 other intervention for Systemic Lupus Erythematosus. Completed, enrolled 106 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartFeb 2009
Primary CompletionFeb 2011
TodayJul 2026
First PostedJan 23, 2009
Enrollment StartFeb 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.4 years ago
Interventions
Omega-3drug
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