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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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13 October 2020 |
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Main ID: |
EUCTR2004-004404-21-GB |
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Date of registration:
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17/02/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in Lupus
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Scientific title:
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Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in Lupus |
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Date of first enrolment:
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10/12/2004 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004404-21 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind: yes
Parallel group: yes
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo: yes
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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:
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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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
Concentration number: 1.8-
INN or Proposed INN: Docosahexaenoic acid
CAS Number: 25167-62-8
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-
INN or Proposed INN: alpha-tocopherol
CAS Number: 1406-18-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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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Secondary Objective: To observe the clinical benefits in SLE patients given fish oils
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Main Objective: To investigate the potential changes in endothelial function and free radical production in SLE patients with the addition of fish oils
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Secondary ID(s)
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SLE-Omega
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 01/06/2003
Contact:
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