Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in PD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 主要终点
- nitrogen balance,residual renal function and nutritional status
研究概览
简要总结
Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.
详细描述
Dietary protein is the major source of nitrogen excreted as urea by the kidney, and a decreased protein intake has been associated with a retardation of kidney function loss in non-dialysis chronic kidney disease (CKD) patients. While a low protein diet is recommended to end-stage renal disease (ESRD) patients before the start of dialysis to preserve residual renal function(RRF), current therapy recommendations in dialysis are for a normal protein intake of no less than 1.2 g of protein/kg ideal body weight (IBW)/day to prevent protein-energy wasting (PEW).
We hypothesized that a lower protein intake would be safe and able to slow the loss of RRF also in dialysis patients and conducted two prospective, randomized trials involving a total of 94 peritoneal dialysis (PD) patients to test our hypothesis.
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
- None
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
- •age 18-80 years
- •stable peritoneal dialysis since at least 1 month
- •with renal function
排除标准
- •a high probability (assessed by the recruiting physician) of receiving a kidney transplant within one year
- •overt infection within the last month
- •poor compliance in previous dietary prescriptions or irregular check-ups
- •persistent anorexia, vomiting or diarrhea within the last month
- •a CRP of more than 30 mg/dL
- •presence of wasting diseases such as cancer or tuberculosis
结局指标
主要结局
nitrogen balance,residual renal function and nutritional status
时间窗: 10 day and 1 year
次要结局
未报告次要终点