Condition category
Musculoskeletal Diseases
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
18/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.qub.ac.uk/

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17875549

Publication citations

  1. 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.

Additional files

Editorial Notes