Feasibility of conducting a randomized, placebo-controlled study assessing whether omega-3 fatty acids prevent gout flares when starting urate-lowering treatment

Autor: Abhishek Abhishek, Amy Fuller, Georgina Nakafero, Weiya Zhang, Jennifer Dumbleton, Christopher Hawkey, Carol Coupland, Robert Terkeltaub, Michael Doherty
Rok vydání: 2022
Předmět:
Zdroj: Rheumatology advances in practice. 6(3)
ISSN: 2514-1775
Popis: Objective The aim was to test the feasibility of a randomized controlled trial exploring whether omega-3 fatty acid supplementation limits gout flares during treat-to-target urate-lowering treatment (T2T-ULT). Methods Adults with at least one gout flare in the past 12 months and serum urate (SU) ≥360 μmol/l were recruited from general practices (primary method) and randomly assigned 1:1 to receive omega-3 fatty acid supplementation (4 g/day) or placebo for 28 weeks. At week 5, participants began T2T-ULT. The primary outcome was drop-out rate. Secondary outcomes were recruitment rate, outcome data completeness, the number, severity and duration of gout flares between weeks 5 and 28, and study drug compliance. Results Ninety-five per cent of randomized participants (n = 60) completed all study visits. The primary method recruitment rate was 2.2%. Fifty and 42 participants achieved SU Conclusion The study demonstrated feasibility and provided useful metrics for conducting a community-based gout flare prophylaxis trial. Study registration ISRCTN; https://www.isrctn.com/; ISRCTN79392964.
Databáze: OpenAIRE