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

David Shonka, MD

Status and phase: Completed; Phase 2

Conditions: Hypocalcemia; Thyroid Nodules

Treatments: Dietary Supplement: Control Pill; Dietary Supplement: Calcitriol

Study type: Interventional

Funder types: Other

Identifiers

NCT01868750

16544

Details and patient eligibility

About

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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

Vitamin D (Calcitriol)

Active Comparator group

Description:

Calcitriol, 1.0ug twice daily for 7 days prior to surgery

Treatment:

Dietary Supplement: Calcitriol

Control

Placebo Comparator group

Description:

Placebo pill taken twice daily for 7 days prior to surgery

Treatment:

Dietary Supplement: Control Pill