Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With a Urine Albumin Excretion Decrease of 20% or More
研究概览
简要总结
To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and vascular function and inflammatory parameters in patients with chronic renal disease
详细描述
In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of corn oil during 12 weeks, will be assessed on the following parameters:
- Urine albumin excretion
- Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin
- Carotid intima media thickness and pulse wave velocity
- Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6
- Metabolic control of diabetes
- Serum lipid levels
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urinary albumin excretion over 30 mg/g creatinin
- •Chronic renal failure stage 2 to 4
- •Absence of serious conditions such as cáncer, decompensated heart failure, chronic infections and severe arterial lesions
排除标准
- •Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8%
- •Presence of cognitive impairment that does not allow to sigin a written informed consent
- •Alcohol or illicit drug abuse
研究组 & 干预措施
Omega 3 fatty acids
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
干预措施: Omega 3 fatty acids (Dietary Supplement)
Corn oil
Supplementation of 3.7 g of corn oil per day during 12 weeks
干预措施: Corn oil (Dietary Supplement)
结局指标
主要结局
Number of Participants With a Urine Albumin Excretion Decrease of 20% or More
时间窗: At baseline and 12 weeks of intervention
Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more
次要结局
- Change in C Reactive Protein Levels at 12 Weeks of Intervention(At baseline and 12 weeks of intervention)
- Change in Pulse Wave Velocity at 12 Weeks of Intervention(At baseline and 12 weeks of intervention)
研究者
Daniel Bunout
Full profesor
University of Chile