Omega–3 fatty acids for preventing acute attacks of gout - a feasibility study

Phase 2

Completed

• Conditions: Gout; Musculoskeletal Diseases

• Registration Number: ISRCTN79392964
• Lead Sponsor: ottingham University Hospital NHS Trust

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36407800/ (added 22/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-08
• Study Completion: 2020-07-27
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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 <85 g/L
13.2. WCC <3.5 x 109/L
13.3. Neutrophils <1.5 x 109/L
13.4. Platelets <100 x 109/L
13.5. ALT >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dropout rate defined as number of patients randomised that remain in the study until end of follow-up at 28 weeks