Gout Musculoskeletal Diseases Gout
Conditions
Interventions
Randomisation: 1:1 individual randomisation
Randomisation time: Randomisation will occur once the results of screening blood tests performed at the screening visit are reviewed and el
containing 3.36 g of omega-3 fatty acids)
Control: placebo capsules (4 g olive oil/day)
After four weeks participants in both arms will be commenced on up-titrated ura
Sponsors
Nottingham University Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. GP/physician-diagnosed gout 2. Meets the American College of Rheumatology/European League against Rheumatism (EULAR) classification criteria for gout 3. Willing to commence on urate-lowering treatment 4. Serum uric acid = 360 µmol/L at the screening visit 5. Age = 21 years at the screening visit 6. Able to give informed consent 7. No change in the average weekly dose of analgesics for at least 4 weeks prior to the screening visit 8. Be able to adhere to the study visit schedule and other protocol requirements 9. Subjects able to communicate well with the investigator or designee, to understand and comply with the requirements of the study and to understand and sign the written informed consent
Exclusion criteria
Exclusion criteria: 1. Other defined inflammatory arthritis e.g. reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme’s disease, or plaque psoriasis 2. Other autoimmune inflammatory conditions like moderate/severe asthma or inflammatory bowel disease requiring corticosteroids or immune-suppressing treatments 3. Active solid organ cancer 4. Dementia 5. Serious co-morbidities preventing prescription of treatment 6. On regular daily NSAIDs, prednisolone, and unable to discontinue them 7. On long-term anticoagulation: Because of the mild increase in bleeding time with 4 gm/day omega-3 fatty acids, there is a potential interaction with warfarin and an increased possibility of haemorrhage in patients at high risk because of severe trauma, surgery, etc. Patients receiving anticoagulant therapy will therefore be excluded. 8. Oral, intramuscular, intra-arterial, or intravenous corticosteroids during the last 1 month 9. Known allergy to omega-3 fatty acids, gelatine, olive oil, and soya 10. Pregnant or planning to become pregnant during the treatment period 11. Use of any investigational (unlicensed) drug within 3 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer 12. Evidence of serious uncontrolled concomitant medical condition, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, gastro-intestinal disease or epilepsy, which in the opinion of the investigator makes them unsuitable for the study 13. Significant haematological or biochemical abnormality: 13.1. Haemoglobin 1.5 times upper limit of normal 13.6. Creatinine >2 times upper limit of normal Potential participants deemed ineligible at the screening will be allowed a second screening visit if the ineligibility status is temporary e.g. recent corticosteroid use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dropout rate defined as number of patients randomised that remain in the study until end of follow-up at 28 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate recorded as the number of eligible participants based on self-reported number of gout flares in initial gout questionnaire who are randomised in the study. 2. The proportion of patients approached by the GP with information about the study and requested to return the reply slip to the study team, who complete the following by the end of the 28-week study: 2.1. Reply to Academic Rheumatology, University of Nottingham 2.2. Meet the eligibility criteria on telephone screening and based on reply to the initial gout questionnaire 2.3. Agree for screening visit 2.4. Meet the eligibility criteria after checking serum uric acid, full blood count, liver and kidney function tests 2.5. Are randomised into the trial 3. The number of gout flares measured using gout diary between weeks 5 and 28 of the study 4. The severity of gout flares defined as an average of daily pain visual analogue scale (0-100) during a gout flare between weeks 5 and 28 of the study. Calculated by sum of daily pain scores divided by number of days on which the gout flare is present 5. The number of days gout flares were experienced by each participant measured using gout diary between weeks 5 and 28 of the study 6. The number of participants who withdrew themselves from the study due to side effects related to omega-3 fatty acids between weeks 0 and 28 of the study 7. The number of participants not on ULT at each GP surgery at the start of recruitment when surgeries complete the mail-out 8. Compliance with study drug measured by capsule count at weeks 14 and 28 | — |
Countries
England, United Kingdom
Outcome results
None listed