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临床试验/ISRCTN15087616
ISRCTN15087616进行中(未招募)4 期

atural vitamin D (cholecalciferol) versus standard care in patients receiving dialysis - The SIMPLIFIED randomised registry trial

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 4,200 人开始时间: 2015年12月30日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
4,200

研究概览

简要总结

2015 presented at 3rd International Clinical Trials Methodology Conference in http://doi.org/10.1186/1745-6215-16-S2-O15 (added 10/05/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged 18 years or over
  • 2. Have given written informed consent to participate
  • 3. UK Resident
  • 4. Have dialysis-requiring end stage renal disease (ESRD)

排除标准

  • Current exclusion criteria as of 23/11/2017:
  • 1. Current treatment with high dose (>1,000IU/day) cholecalciferol or ergocalciferol in the last 30 days
  • 2. Persistent hypercalcaemia (>2.62 mmol/l on three separate and sequential occasions without precipitating cause)
  • 3. Life expectancy of less than 6 months
  • 4. Women who are pregnant / planning to become pregnant
  • 5. Hypersensitivity to colecalciferol or any of the excipients
  • 6. Not contributing, or willing to contribute, data to the UK Renal Registry (UKRR)
  • Previous exclusion criteria:
  • 1. Current treatment with high dose (>1,000IU/day) cholecalciferol
  • 2. Persistent hypercalcaemia (>2.62 mmol/l on three separate and sequential occasions without precipitating cause)
  • 3. Life expectancy of less than 6 months
  • 4. Women who are pregnant / planning to become pregnant
  • 5. Inability to provide informed consent
  • 6. Not contributing, or willing to contribute, data to the UK Renal Registry (UKRR)

研究者

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