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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thyroid Nodules, Hypocalcemia

Intervention / Treatment
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* Dietary Supplement: Calcitriol
* Dietary Supplement: Control Pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D (Calcitriol)<br>Calcitriol, 1.0ug twice daily for 7 days prior to surgery | Dietary Supplement: Calcitriol<br>* 1.0ug twice daily for 7 days before surgery<br>|
| Placebo Comparator: Control<br>Placebo pill taken twice daily for 7 days prior to surgery | Dietary Supplement: Control Pill<br>* placebo pill taken twice daily for 7 days before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of Hypocalcemia | Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay | 2-5 days after surgery |