ISRCTN79392964已完成2 期
Omega–3 fatty acids for the prophylaxis of acute attacks of gout on initiating urate-lowering treatment – a feasibility study for a randomised controlled trial
ottingham University Hospital NHS Trust0 个研究点目标入组 60 人开始时间: 2019年8月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36407800/ (added 22/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
不适用
Omega 3 fatty acid treatment in patients with epilepsyEpilepsyNervous System DiseasesISRCTN57643242Faculty of Life Sciences and Computing, London Metropolitan University (UK)99
已完成
不适用
Omega 3 fatty acid for prevention of sickle cell crisisSickle cell anaemia (HbSS)Haematological DisordersSickle-cell anaemia without crisisISRCTN80844630Mother and Child Foundation (UK)140
已完成
不适用
Effect of omega 3 in the prevention of 30-days major adverse cardiovascular events following Carotid StentingIRCT2017011120441N6Shiraz University of Medical Sciences, Vice Chancellor of Research60
进行中（未招募）
不适用
Omega-3 fatty acids for Prevention of post-opERative Atrial fibrillation (OPERA) - OPERAPatients scheduled for cardiac surgeryMedDRA version: 9.1Level: SOCClassification code 10007541EUCTR2009-017582-29-ITCONSORZIO MARIO NEGRI SUD1,516
已完成
不适用
Chronic omega-3 fatty acid supplementation in type 1 diabetesNutritional, Metabolic, EndocrineType 1 DiabetesISRCTN40811115eeds Beckett University20