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临床试验/NCT02876822
NCT02876822终止不适用

Safety and Efficacy of Single, High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Serum 25OHD level

研究概览

简要总结

The purpose of this study is to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

详细描述

Vitamin D deficiency is common in childhood and has been associated with increased incidence of graft versus host disease (GVHD) and decreased survival in patients undergoing hematopoietic stem cell transplantation (HSCT). Recently, quality improvement efforts to correct serum vitamin D levels among inpatients at CCHMC who have already received HSCT and who were vitamin D deficient suggest that current recommended doses of vitamin D are inadequate to treat vitamin D deficiency. Possible hindrances to vitamin D treatment in the HSCT population include malabsorption related to gut GVHD, mucositis, increased requirement for calcium and/or vitamin D, kidney disease, liver disease, and infection. Single, high dose vitamin D treatment (stoss-therapy) has been utilized effectively to treat rickets and other chronic illnesses such as cystic fibrosis in children. The investigators hypothesize that stoss-therapy provided orally prior to transplantation will result in rapid and sustained correction of vitamin D deficiency in children who require HSCT. The investigators propose to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

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

性别
All
接受健康志愿者

入选标准

  • Step 1: Patients who are preparing for HSCT, 25OHD level (<50 ng/mL), and no prior history of HSCT.
  • Step 2: Patients who are preparing for HSCT 25OHD level (<50 ng/mL).
  • Exclusion Criteria (both Step 1 and Step 2):
  • Patients with history of pathologic fractures,
  • uncorrected hypocalcemia or hypophosphatemia,
  • known history of nephrocalcinosis or nephrolithiasis,
  • current granulomatous disease,
  • those currently in ICU.

排除标准

  • 未提供

结局指标

主要结局

Serum 25OHD level

时间窗: Weekly for 8 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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