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临床试验/NCT02073136
NCT02073136已完成不适用

Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Phosphate balance

研究概览

简要总结

Patients with chronic kidney disease struggle to eliminate phosphate as the renal function deteriorates, which results in accumulation of phosphate in the body. This has been shown to increase the patients' risk of cardiovascular disease and death. Even with dialysis treatment the patients cannot excrete enough phosphate to reach phosphate balance. The patients are therefore recommended a very restrictive diet when they reach the dialysis stage. It is therefore important to find ways to prevent such accumulation of phosphate in the body as early in the disease process as possible, but without compromising the nutritional status. Because phosphate occurs naturally in many of our foods, such as meat, fish and dairy products, it is difficult to reduce the intake of phosphate, without also reducing the intake of energy and protein. Over the past couple of years there has been an increased focus on the use of phosphate containing additives in the food industry. A reduction in the intake of phosphorus containing additives may reduce the accumulation of phosphate in the body. This can be achieved by decreasing the intake of processed food products. Because it is also very time consuming and inconvenient for the patient to keep these strict diets, the patients have a reasonable claim to know which effects can be achieved by such diets. This will therefore seek to be further explored in the following study. The study is conducted as a randomised crossover trial in predialysis patients stage 3-4.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Patients > 18 years.
  • Diagnosed with Chronic Kidney Disease stage 3-4 (GFR 15-59 ml / min)
  • p-phosphate between 0.85 mmol / L (2.7 mg / dL) and 1.50 mmol / L (4.7 mg / dl)
  • Read and understand Danish
  • Have received oral and written information about the study
  • Signed informed consent form

排除标准

  • Diagnosed hyperphosphatemia
  • Diagnosed hyperparathyroidism
  • Treatment with phosphate binders
  • Dysphagia
  • Diagnosed with decreased absorption capacity in the intestine
  • Co-morbidities in liver, pancreas or lungs
  • Pregnancy / breastfeeding
  • Embedded within the last 4 weeks
  • Kidney transplant
  • Terminal patients

结局指标

主要结局

Phosphate balance

时间窗: 1 week

次要结局

  • p-phosphate(1 week)
  • p-PTH(1 week)
  • FGF23(1 week)
  • p-alkaline phosphatase(1 week)
  • p-Calcium(1 week)
  • Calcium-phosphate product(1 week)
  • p-25(OH)D(1 week)

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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