Fish Oils in Lupus
| ISRCTN | ISRCTN66445141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66445141 |
| EudraCT/CTIS number | 2004-004404-21 |
| Secondary identifying numbers | 073400 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 18/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gary McVeigh
Scientific
Scientific
Queen's University of Belfast
Whitla Medical Building
Department of Therapeutics and Pharmacology
97 Lisburn Road
Belfast
BT7 1BL
United Kingdom
| Phone | +44 (0)28 9097 5770 |
|---|---|
| g.mcveigh@qub.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Omega-3-polyunsaturated fatty acids and atherosclerosis in systemic lupus erythematosus: cellular mechanisms and functional consequences |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2005 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Patients (adult, either sex) fulfilling American College of Rheumatology (ACR) classification criteria for SLE. |
| Key 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. |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Queen's University of Belfast
Belfast
BT7 1BL
United Kingdom
BT7 1BL
United Kingdom
Sponsor information
Queen's University of Belfast (UK)
University/education
University/education
Lanyon North
Regional Research Services
University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
| Phone | +44 (0)28 9097 2568 |
|---|---|
| d.weir@qub.ac.uk | |
| Website | http://www.qub.ac.uk/ |
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 073400)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2008 | Yes | No |
