A Phase 2, Placebo-controlled, Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Measure of Serum Calcium Levels
研究概览
简要总结
One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. Severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a few extra days in the hospital.
The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the calcium needed to make strong bones and teeth. The purpose of this study is to determine if taking vitamin D before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient referred for thyroidectomy
- •Agreement to use contraception prior to and during the study
排除标准
- •Hypercalcemia (>10.5mg/dL)
- •Chronic kidney or parathyroid disease
- •Cardiac or Central Nervous System disease
- •Pregnant or breastfeeding women
结局指标
主要结局
Measure of Serum Calcium Levels
时间窗: 2-5 days after surgery
Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia
次要结局
- Evidence of Hypocalcemia(2-5 days after surgery)
研究者
David Shonka, MD
Assistant Professor
University of Virginia
