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11 February 2012
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| [ Print-friendly version ] |
| Fish Oils in Lupus |
| ISRCTN | ISRCTN66445141 |
| ClinicalTrials.gov identifier | |
| Public title | Fish Oils in Lupus |
| Scientific title | Omega-3-polyunsaturated fatty acids and atherosclerosis in systemic lupus erythematosus: cellular mechanisms and functional consequences |
| Acronym | N/A |
| Serial number at source | 073400 |
| Study hypothesis |
AIMS:
1. To examine platelet free radical (nitric oxide and superoxide) generation in Systemic Lupus Erythematosus (SLE) 2. To examine endothelial function and vascular reactivity in systemic lupus erythematosus at global, local and microvascular levels 3. To examine the effect of omega-3 polyunsaturated fatty acids in relation to markers of platelet activation, vascular reactivity and disease activity in systemic lupus erythematosus |
| Lay summary | |
| Ethics approval |
QUB Research Ethics Committee (reconstituted to ORECNI 2004) gave approval on the 28th May 2003 (MHRA letter of approval on 10th December 2004). Reference numbers:
1. Ethics: 158/03 2. Trust: 04/SW/114 3. Eudract No.: 2004-004404-21 4. CTA No.: 21993-0002-001-0001 |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Systemic Lupus Erythematosus (SLE) |
| Participants - inclusion criteria | Patients (adult, either sex) fulfilling American College of Rheumatology (ACR) classification criteria for SLE. |
| Participants - exclusion criteria |
1. Diabetes mellitus (fasting blood glucose more than 7.8 mmol/l)
2. Hypertension of systolic more than 160 mmHg or diastolic more than 90 mmHg (as determined by the mean of three readings taken on the first visit) 3. Carcinoma (other than superficial skin carcinoma) 4. Significant pulmonary, hepatic or renal disease 5. Typical angina or myocardial infarction 6. Active infectious diseases 7. Use of antihypertensive, oral hypoglycaemic or lipid lowering agent (in the last three months) 8. Cyclophosphamide therapy (due to potential to interfere with acetylcholinesterase) 9. Glucocorticoids equivalent to greater than 10 mg prednisolone 10. All pregnant or lactating women will be excluded. |
| Anticipated start date | 01/01/2005 |
| Anticipated end date | 01/08/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 60 |
| Interventions |
SLE subjects will be randomised to either fish oil capsules or placebo for a 24 week period. The patients will have measures of endothelial function and vascular reactivity, free radical activity and markers of disease activity taken at baseline, 12 weeks and at 24 weeks.
Joint sponsor details: Greenpark Healthcare Trust Research Department Musgrave Park Hospital Stockmans Lane Belfast BT9 7JB Northern Ireland Tel: +44 (0)28 9090 2000 Fax: +44 (0)28 9066 1112 email: ruth.alexander@greenpark.n-I.nhs.uk |
| Primary outcome measure(s) | Improved nitric oxide bioactivity and reduced superoxide bioactivity. |
| Secondary outcome measure(s) | Improved vascular reactivity and endothelial function, clinical response as measured by Revised activity index of Systemic Lupus Activity Measure (SLAM-R), Systemic Lupus International Collaborating Clinics (SLICC) and British Isles Lupus Assessment Group (BILAG). |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 073400) |
| Trial website | |
| Publications | 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17875549 |
| Contact name | Dr Gary McVeigh |
| Address |
Queen's University of Belfast
Whitla Medical Building Department of Therapeutics and Pharmacology 97 Lisburn Road |
| City/town | Belfast |
| Zip/Postcode | BT7 1BL |
| Country | United Kingdom |
| Tel | +44 (0)28 9097 5770 |
| Fax | +44 (0)28 9043 8346 |
| g.mcveigh@qub.ac.uk | |
| Sponsor | Queen's University of Belfast (UK) |
| Address |
Lanyon North
Regional Research Services University Road |
| City/town | Belfast |
| Zip/Postcode | BT7 1NN |
| Country | United Kingdom |
| Tel | +44 (0)28 9097 2568 |
| Fax | +44 (0)28 9097 2570 |
| d.weir@qub.ac.uk | |
| Sponsor website: | http://www.qub.ac.uk/ |
| Date applied | 22/07/2005 |
| Last edited | 26/01/2009 |
| Date ISRCTN assigned | 22/07/2005 |
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