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
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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