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临床试验/NCT04600193
NCT04600193Unknown不适用

a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年3月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
2
主要终点
Plasma levels of phosphate

研究概览

简要总结

Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. But since phosphate exists in both organic and inorganic forms in the diet, this leads to several problems. Informations of the bioavability and furthermore the effect of plasma koncentrations of phosphate are lacking for both forms of phosphate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years
  • Competent
  • The patient should be able to take a sample of p-fluid and urine by himself
  • Chronic peritoneal dialysis
  • Reads and understand danish
  • Has been informed written and oraly about the study and signed informed consent
  • P-phosphate koncentrations 0,7-2,0 .mol/l
  • P - ioniset calcium 1,1-1,4 mmol/l

排除标准

  • Pregnant or breast-feeding
  • Terminal patients
  • If the experience acute infections or other acute situations they will be excluded from the study

结局指标

主要结局

Plasma levels of phosphate

时间窗: six days

次要结局

  • Changes in p-sodium(six days)
  • Changes in p-magnesium(six days)
  • changes in p-calcium(six days)
  • Koncentration of phosphate in peritoneal dialysis fluid(six days)
  • Changes in p-phosphate(six days)
  • changes in p-PTH(six days)
  • Changes in p-potassium(six days)
  • Changes in p-FGF23(six days)
  • Koncentration of phosphate in urine(six days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Rikardt Andersen

Associate professor at the university of Copenhagen

University of Copenhagen

研究点 (2)

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