Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Estimated glomerular filtration rate
研究概览
简要总结
The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen
详细描述
Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.
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
- Single (Participant)
盲法说明
There will be no masking of the treatment arm for researchers
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated glomerular filtration rate of less tan 25/ml/min/1.73m2
- •Not on renal substitution therapy
- •Absence of severe life threatening concomitant diseases
排除标准
- •Malignant or renovascular hypertension
- •Use of systemic steroids or immunosuppressant drugs
- •Alcohol or illicit drug abuse
- •A body mass index of less tan 18 kg/m2
结局指标
主要结局
Estimated glomerular filtration rate
时间窗: 16 weeks
glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C
Urinary urea nitrogen excretion
时间窗: 16 weeks
Measurement of urea nitrogen i na spot urine sample
次要结局
未报告次要终点
研究者
Eduardo Lorca
Chief Cardiovascular Program
University of Chile
