ISRCTN27673620已完成不适用
Vitamin D replacement to prevent acute lung injury following oesophagectomy - a randomised placebo controlled trial
niversity of Birmingham (UK)0 个研究点目标入组 80 人开始时间: 2011年12月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
- 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782429 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30222631
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre
- •2. Aged over 18 years on day of first dose of investigational medicinal product (IMP)
- •3. Ability to give written informed consent to participate in the study
排除标准
- •1. Known intolerance of vitamin D
- •2. Known sarcoidosis, hyperparathyroidism, or nephrolithiasis
- •3. Taking more than 1000iu/day vitamin D supplementation in the month preceding enrolment
- •4. Baseline serum corrected calcium >2.65 mmol/L
- •5. Undergoing haemodialysis
- •6. Pregnant or breastfeeding
- •7. Taking cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
- •8. Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP
- •9. Diagnosis of COPD with an FEV1 less than 50% predicted or resting oxygen saturations of less 92%
研究者
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