Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in Lupus
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- EUCTR2004-004404-21-GB
- Lead Sponsor
- GreenPark Healthcare Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Patients fulfilling ACR classification criteria for SLE
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
diabetes mellitus (fasting blood glucose >7.8mmol/l); hypertension of systolic >160mmHg or diastolic >90mmHg (as determined by the mean of three readings taken on the first visit); carcinoma (other than superficial skin carcinoma); significant pulmonary, hepatic or renal disease; typical angina or myocardial infarction; active infectious diseases; use of antihypertensive, oral hypoglycaemic or lipid lowering agent (in the last 3 months); cyclophosphamide therapy (due to potential to interfere with acetlycholinesterase); glucocorticoids equivalent to greater than 10mg prednisolone. All pregnant or lactating women will be excluded
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the potential changes in endothelial function and free radical production in SLE patients with the addition of fish oils;Secondary Objective: To observe the clinical benefits in SLE patients given fish oils;Primary end point(s): Primary Outcomes: Increased nitric oxide bioactivity & reduced superoxide production with fish oil supplementation.<br><br>Secondary Outcomes: Improved vascular reactivity & clinical response with fish oil supplementation
- Secondary Outcome Measures
Name Time Method