Contact information
Type
Scientific
Primary contact
Dr Gary McVeigh
ORCID ID
Contact details
Queen's University of Belfast
Whitla Medical Building
Department of Therapeutics and Pharmacology
97 Lisburn Road
Belfast
BT7 1BL
United Kingdom
+44 (0)28 9097 5770
g.mcveigh@qub.ac.uk
Additional identifiers
EudraCT number
2004-004404-21
ClinicalTrials.gov number
Protocol/serial number
073400
Study information
Scientific title
Omega-3-polyunsaturated fatty acids and atherosclerosis in systemic lupus erythematosus: cellular mechanisms and functional consequences
Acronym
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Systemic Lupus Erythematosus (SLE)
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Fish oil capsules
Primary outcome measure
Improved nitric oxide bioactivity and reduced superoxide bioactivity.
Secondary outcome measures
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).
Overall trial start date
01/01/2005
Overall trial end date
01/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (adult, either sex) fulfilling American College of Rheumatology (ACR) classification criteria for SLE.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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.
Recruitment start date
01/01/2005
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's University of Belfast
Belfast
BT7 1BL
United Kingdom
Sponsor information
Organisation
Queen's University of Belfast (UK)
Sponsor details
Lanyon North
Regional Research Services
University Road
Belfast
BT7 1NN
United Kingdom
+44 (0)28 9097 2568
d.weir@qub.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 073400)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17875549
Publication citations
-
Results
Wright SA, O'Prey FM, McHenry MT, Leahey WJ, Devine AB, Duffy EM, Johnston DG, Finch MB, Bell AL, McVeigh GE, A randomised interventional trial of omega-3-polyunsaturated fatty acids on endothelial function and disease activity in systemic lupus erythematosus., Ann. Rheum. Dis., 2008, 67, 6, 841-848, doi: 10.1136/ard.2007.077156.