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临床试验/NCT01868750
NCT01868750已完成2 期

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

David Shonka, MD2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2013年5月最近更新:
适应症

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

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

发起方
David Shonka, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Shonka, MD

Assistant Professor

University of Virginia

研究点 (2)

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