Phase 4
N=87
Efficacy of Fish Oil in Lupus Patients
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT00828178 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. — 0.32; 0.33; 0.32; 0.33 cm — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omega-3 (Drug); flow-mediated dilation of the brachial artery (Device); corn starch (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michelle Petri M.D.,MPH
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. |
0.32; 0.33; 0.32; 0.33 | 0.87 |
| SECONDARY Effect of Omega-3 Versus Placebo on Disease Activity in SLE. |
1.5; 1.5; 0.49; 0.41 | 0.1801 |
| SECONDARY Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo. |
-1.61; -5.56; -17.52; 26.57 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00828178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.