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临床试验/NCT01325610
NCT01325610已完成不适用

The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis

Creighton University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Vitamin D Status as measured by 25(OH)D levels

研究概览

简要总结

The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD) (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D levels in CKD by general healthy population guidelines.

  1. This project focuses on an outcome (calcium absorption) that may be impacted by optimizing 25D status in renal patients. The investigators will assume for this project that a level of 25D > 32 ng/ml is optimal in CKD patients as in a healthy population.
  2. A secondary outcome is to quantify calcium absorption in CKD patients with and without vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles 25D and 1,25D play in calcium absorption.

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

入选标准

  • on hemodialysis
  • > 19 years of age

排除标准

  • Pregnancy or planned pregnancy
  • Hypercalcemia (> 10.2 mg/dl) at baseline
  • Chronic GI disease
  • Liver dysfunction
  • Taking steroids
  • Received any investigational drugs within 4 weeks
  • Any allergy to vitamin D3
  • Chronic vitamin D intake > 1,000 IU daily
  • Dialysate concentration (calcium 2.5mg/L) which is to remain constant during Rx

结局指标

主要结局

Vitamin D Status as measured by 25(OH)D levels

时间窗: 12 weeks

A weekly dose of 20,000 IU of vitamin D3 will be taken by the particpant and blood drawn to measure levels at weeks 1, 3, 5, 8, 10, 13, and 18.

次要结局

  • Calcium Absorption(12 weeks)

研究者

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

Laura Armas

Assistant Professor

Creighton University

研究点 (2)

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