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

Phase 2

Completed

• Conditions: Hypocalcemia; Thyroid Nodules
• Interventions: Dietary Supplement: Calcitriol; Dietary Supplement: Control Pill

• Registration Number: NCT01868750
• Lead Sponsor: David Shonka, MD

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 Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-04
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D (Calcitriol)	Calcitriol	Calcitriol, 1.0ug twice daily for 7 days prior to surgery
Control	Control Pill	Placebo pill taken twice daily for 7 days prior to surgery

Primary Outcome Measures

Name	Time	Method
Measure of Serum Calcium Levels	2-5 days after surgery	Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia

Secondary Outcome Measures

Name	Time	Method
Evidence of Hypocalcemia	2-5 days after surgery	Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States