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临床试验/NCT00755690
NCT00755690已完成不适用

Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease

University of British Columbia1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年9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
32
试验地点
1
主要终点
FGF-23

研究概览

简要总结

This study is designed to describe the physiological response to increased and decreased dietary phosphate intake on various parameters of mineral metabolism in the blood and urine of individuals with Chronic Kidney Disease stage 3 and 4 with normal serum phosphate levels. This detailed study will give us a far greater understanding of the role of diet in abnormal mineral homeostasis early in the progression of this chronic disease. The findings of this study will help both physicians and dietitians better determine the optimal time to introduce dietary therapy in CKD.

详细描述

The potential benefits of implementation of phosphate management earlier in CKD (Stages 3/4) are threefold: 1) prevention of vascular damage early in the progression of CKD thus reducing risk of cardiovascular death 2) Improved management of renal bone disease and resultant co-morbidities and 3) slowing the progression of renal failure lengthening the time required till dialysis is required. Although dietary counseling is currently a normal part of CKD care, the utility and effectiveness of lowering phosphate has not previously been quantified. In part this is due to the difficulty of measurement of serum phosphate as it is so tightly controlled before GFR falls below 30mls/min. No studies have investigated whether is it possible to modulate circulating FGF-23 and phosphate excretion in early stages of renal failure using diet in individuals with normal serum phosphate levels.

Study Objectives ;

  1. To measure FGF-23 levels before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders.
  2. To measure levels of calcium, phosphate, PTH, 25 and 1,25 vitamin D and fractional phosphate excretion before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CKD patients with CKD stage 3 and 4 (eGFR < 60 ml/min and > 15 ml/min per 1.73 m2, not requiring dialysis).
  • Normal serum phosphate stable over three months (> 0.87 mmol/L and < 1.70 mmol/L)
  • Not yet following a low phosphate diet as reported by the patient or the renal dietitian (<1500mg/d)
  • Over 19 years of age

排除标准

  • Body mass index <20 kg/m2
  • Current use of phosphate binders or active vitamin D or phenytonin (which induces vitamin D catabolism)
  • Primary parathyroid defects
  • Diagnosed osteoporosis
  • Gut absorption defects
  • Liver disease
  • Pregnancy or lactation
  • Patients hospitalised within the last 4 weeks

结局指标

主要结局

FGF-23

时间窗: 5 days

次要结局

  • Serum calcium, phosphate, PTH, 25 and 1,25 vitamin D and fractional phosphate excretion.(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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