Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in Lupus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004404-21-GB

Enrollment

Registered

2005-02-17

Start date

2004-12-10

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Interventions

Trade Name: Omacor Product Name: Omacor Pharmaceutical Form: Capsule, soft INN or Proposed INN: Eicosapentaenoic acid CAS Number: 25378-27-2. Concentration unit: g gram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. Secondary Outcomes: Improved vascular reactivity & clinical response with fish oil supplementation	—

Measure

Time frame

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. Secondary Outcomes: Improved vascular reactivity & clinical response with fish oil supplementation

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026