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

Hypocalcemia Clinical Trial

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 Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868750
• Other study ID #: 16544
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: July 8, 2021

Study information

• Verified date: October 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia
• Thyroid Nodule
• Thyroid Nodules

Intervention

Dietary Supplement:
• Calcitriol
1.0ug twice daily for 7 days before surgery
• Control Pill
placebo pill taken twice daily for 7 days before surgery

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
David Shonka, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Serum Calcium Levels	Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia	2-5 days after surgery
Secondary	Evidence of Hypocalcemia	Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay	2-5 days after surgery