Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma-total carbon dioxide (CO2)
研究概览
简要总结
This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for 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. Therefore, we aim to investigate this association through an interventional study design.
Participants will be asked to follow a restricted diet with a low "PRAL" during a 6-week trial divided into three periods: two-week of free-living control, two-weeks of intervention, and a two-week free-living follow-up.
The PRAL calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient. The diet will comply with Danish national guidelines on threshold for potassium and protein, due to the high risk of hyperkalemia in CKD patients. 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-bicarbonate 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, bricker 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 carbon dioxide (CO2)
时间窗: 6 weeks
mmol/l
次要结局
- Urine-creatinine(6 weeks)
- Plasma-parathyroid hormone(6 weeks)
- Urine-pH(6 weeks)
- Plasma-sodium ion(6 weeks)
- Urine-albumin(6 weeks)
- Plasma-creatinine(6 weeks)
- Plasma-carbamide(6 weeks)
- Urine-phosphorous(6 weeks)
- Urine-potassium(6 weeks)
- Urine-magnesium(6 weeks)
- Urine ammonium-ion (NH4+) excretion(6 weeks)
- Plasma-alkaline phosphatase(6 weeks)
- Plasma-albumin(6 weeks)
- Urine-sodium(6 weeks)
- Urine-carbamide(6 weeks)
- Urine-calcium(6 weeks)
- Total acid excretion in urine(6 weeks)
- Urine net acid excretion(6 weeks)
- Urine bicarbonate(6 weeks)