NCT01609439撤回不适用
Pre-operative Vitamin D Supplementation to Reduce Post-operative Hypocalcemia in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hypocalcemia
研究概览
简要总结
The purpose of this study is to determine if pre-operative vitamin D supplementation lowers the incidence of post-operative transient or permanent hypoparathyroidism in patients undergoing total thyroidectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing total thyroidecomty +/- CND
- •Adult (age > or = 18)
排除标准
- •Known chronic kidney disease
- •Known primary hyper or hypoparathyroidism
- •Known hypoalbuminemia
- •Concurrent use medications affecting calcium metabolism
- •Completion hemithyroidectomy
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Treatment
Experimental
Pre-operative Vitamin D 800 units x 4 weeks
干预措施: Vitamin D (Drug)
结局指标
主要结局
Hypocalcemia
时间窗: Transient (<72 hrs post-operatively)
Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa \< 0.9) Need for IV calcium supplementation
次要结局
- Hypocalcemia(Permanent (>4 weeks))
研究者
Caroline Xu
Resident, Otolaryngology-Head and Neck Surgery
University of Alberta
研究点 (1)
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