Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
Conditions
Thyroid Nodules - Hypocalcemia
Conditions: official terms
Hypocalcemia - Thyroid Nodule
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Intervention
Name: Calcitriol Type: Dietary Supplement
Name: Control Pill Type: Dietary Supplement
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient referred for thyroidectomy

- Agreement to use contraception prior to and during the study

Exclusion Criteria:

- Hypercalcemia (>10.5mg/dL)

- Chronic kidney or parathyroid disease

- Cardiac or Central Nervous System disease

- Pregnant or breastfeeding women
Location
University of Virginia
Charlottesville, Virginia, United States
Status: Recruiting
Start Date
May 2013
Completion Date
December 2014
Sponsors
David Shonka, MD
Source
University of Virginia
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page