Clinical Trial: Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase 2, Placebo-controlled, Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidecto

Brief Summary:

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.

Detailed Summary:
Sponsor: David Shonka, MD

Current Primary Outcome: Measure of Serum Calcium Levels [ Time Frame: 2-5 days after surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evidence of Hypocalcemia [ Time Frame: 2-5 days after surgery ]

Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: May 30, 2013
Date Started: May 2013
Date Completion: December 2014
Last Updated: June 19, 2013
Last Verified: June 2013