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临床试验/NCT04013776
NCT04013776Unknown不适用

The Impact of a Low or High Phosphate Diet on Phosphate and Calcium Excretion in Healthy People

Clinical Evaluation Research Unit at Kingston General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

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
Urinary phosphate excretion

研究概览

简要总结

Phosphate is present in many of the foods that the investigators eat and is required by many cellular processes. The kidneys are the only organ that excrete the extra phosphate from the diet that the body does not require. Phosphate is linked to vascular calcification and cardiovascular disease. Measures of serum phosphate do not reflect the burden of phosphate and are not sensitive to early changes in the way the kidneys eliminate phosphate. This study will determine whether the kidneys handle an oral phosphate load differently after 5 days of a low phosphate diet compared to 5 days of a high phosphate diet.

详细描述

In this study, participants will follow a low-phosphorus diet (750 mg) with a 500 mg calcium supplement for 5 days keeping a detailed diary of the foods eaten during this period. On the 5th day, the participant will undergo a 24 hour urine collection. Participants will present after an overnight fast for baseline blood and urine measurements. Then they will consume water containing 500 mg of phosphorus. Urine and blood will be collected every hour for 3 hours for measurement of phosphate and calcium and for measurement of hormones known to regulate phosphate and calcium including fibroblast growth factor-23, parathyroid hormone and vitamin D. One week later, participants will follow the same diet but will also receive a 1250 mg phosphorus supplement for 5 days. On the 5th day, urine will be collected for 24 hours. Participants will present again after an overnight fast and undergo the identical testing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • between ages of 20 and 40

排除标准

  • known heart disease
  • known diabetes
  • breast-feeding

研究组 & 干预措施

Phosphate supplemented diet

Active Comparator

All participants will undergo phosphate testing after following a phosphate supplemented diet for 5 days

干预措施: Phosphate supplemented diet (Dietary Supplement)

Low phosphate diet

No Intervention

All participants will undergo phosphate testing after following a low phosphate diet for 5 days

结局指标

主要结局

Urinary phosphate excretion

时间窗: 3 hours

Change in urinary phosphate excretion after 500 mg phosphorus challenge

次要结局

未报告次要终点

研究者

发起方
Clinical Evaluation Research Unit at Kingston General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Rachel Holden

Professor of Medicine Queen's University

Clinical Evaluation Research Unit at Kingston General Hospital

研究点 (2)

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