Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma-total CO2
研究概览
简要总结
The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control.
The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.
详细描述
Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. The aim is to investigate this association with an interventional studydesign.
Participants will be asked to follow a restricted diet with a low "PRAL" during a 6 week trial divided in three periodes: two week free living control, two week intervention and a two week free living follow-up.
The PRAL calculation tool will be used to create a diet low in acid, based on this the patients will receive individual diet plans. The diet will comply with national treshold guidelines for potassium and protein, this is due to the high risk of hyperkalemia in patients with chronic kidney disease. The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24 hour period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Chronic acidosis (plasma-bicarbonat under 22 mmol/l at multiple measures within the last 12 months).
- •Diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (eGFR below 30 ml/min/1,73 m2)
- •Of legal age and over 18 of years
- •Understand danish and understand the written material
- •Able to cooperate about the diet
- •Able to take pictures with their phone or willing to learn
排除标准
- •Vegan and vegetarian with very low intake of animal protein (below 25 g/day)
- •Pregnant or breast feeding
- •Patients with short bowel syndrome, brickre's bladder, pancreatitis or any other known malabsorption problem
- •Potassium above 5 mmol/l
- •Ongoing infection
结局指标
主要结局
Plasma-total CO2
时间窗: 6 weeks
mmol/l
次要结局
- Plasma-creatinine(6 weeks)
- Urine-potassium(6 weeks)
- Uirne-calcium(6 weeks)
- Plasma-sodium ion(6 weeks)
- Urine-phosphorous(6 weeks)
- Urine-albumin(6 weeks)
- Urine-creatinine(6 weeks)
- Total acid excretion in urine(6 weeks)
- Plasma-alkaline phosphatase(6 weeks)
- Urine-carbamide(6 weeks)
- Urine-magnesium(6 weeks)
- Plasma-carbamide(6 weeks)
- Plasma-albumin(6 weeks)
- Urine-pH(6 weeks)
- Urine bicarbonate(6 weeks)
- Plasma-parathyroid hormone(6 weeks)
- Urine-sodium(6 weeks)
- Urine NH4+ excretion(6 weeks)
- Urine net acid excretion(6 weeks)