Switch off gout attack study (SOGAS) version no. 1.0
Research type
Research Study
Full title
Omega–3 fatty acids for the prophylaxis of acute attacks of gout on initiating urate lowering treatment – feasibility study for a randomised controlled trial
IRAS ID
240464
Contact name
Abhishek Abhishek
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Eudract number
2018-000963-99
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Omega-3 fatty acids block several pathways through which urate crystals that cause gout induce inflammation. Our preliminary finding demonstrate that low levels of omega-3 fatty acids in the blood associates with frequent gout attacks, also called flares.
The overall purpose of this study is to examine the feasibility of conducting a multi centre randomised controlled trial to definitely find out whether omega-3 fatty acids prevent flares of gout when starting urate lowering treatment (ULT).
This study will assess the efficiency of recruitment, willingness of patients for
participating in the study, dropout rate, quality of data captured during acute gout attacks, decide the primary outcome for the main trial, and provide data to calculate sample size of the main trial.
Sixty patients will be randomised in a 1:1 ratio to omega-3 fatty acids (four 1 gm capsules, each containing 0.84 gm active drug) or matching placebo.
All participants will be commenced on ULT as per the British Society for Rheumatology guidelines at week 4, and the dose will be increased at 2-3 weekly intervals using a treat to target approach, aiming for serum uric acid <300 µmol/L.Each participant will be in this study for 28 weeks in total.REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0324
Date of REC Opinion
12 Dec 2018
REC opinion
Further Information Favourable Opinion