The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Glomerular filtration rate
研究概览
简要总结
Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
详细描述
There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients.
8 weeks after transplantation, if renal function has stabilized, patients with a eGFR>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR>30 ml/min. Signed informed consent.
排除标准
- •Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor >75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.
研究组 & 干预措施
Omega-3 fatty acids
2,7 g omega-3 fatty acids / day: Omacor 1 g 1 capsule by mouth 3 times a day for 44 weeks.
干预措施: Omega-3 fatty acids (Drug)
Placebo
Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Glomerular filtration rate
时间窗: 44 weeks
Iohexol clearance
次要结局
- Proteinuria(44 weeks)
- Inflammation in the renal transplant(44 weeks)
- Fibrosis in the renal transplant(44 weeks)
- Blood pressure(44 weeks)
- Lipids(44 weeks)
- Body composition(44 weeks)
- Body mass index(44 weeks)
- Fatty acid composition in plasma and renal tissue(44 weeks)
- Heart rate variability(44 weeks)
- Flow mediated dilation(44 weeks)
- Bone mineral density(44 weeks)
- Vitamin D levels(44 weeks)
- Tacrolimus pharmacokinetics(12 weeks)
- Pulse wave velocity and augmentation index(44 weeks)
- Blood glucose(44 weeks)
研究者
Ivar Eide
MD
Oslo University Hospital