A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of SLE are eligible.
- •Patients must be 18 years of age or older and able to give informed consent.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Omega-3 (Drug)
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
干预措施: flow-mediated dilation of the brachial artery (Device)
corn starch
corn starch; flow-mediated dilation of the brachial artery
干预措施: flow-mediated dilation of the brachial artery (Device)
corn starch
corn starch; flow-mediated dilation of the brachial artery
干预措施: corn starch (Other)
结局指标
主要结局
Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.
时间窗: 12 weeks
The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).
次要结局
- Effect of Omega-3 Versus Placebo on Disease Activity in SLE.(pre-treatment(baseline) and post-treatment (after 12 weeks))
- Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.(pre-treatment(baseline) and post-treatment (after 12 weeks))
研究者
Michelle Petri M.D.,MPH
Principal investigator
Johns Hopkins University