This randomized phase II trial studies how well vitamin D supplementation using calcitriol works in preventing loss of calcium when given before surgery to patients undergoing thyroidectomy. One of the side effects of removing the thyroid is low calcium levels in the blood, or hypocalcemia. Low calcium levels can cause symptoms such as numbness, tingling, or cramping, or more severe effects. Vitamin D is needed by the body to absorb calcium. It is not yet known if giving vitamin D before surgery can help prevent the loss of calcium after surgery in patients undergoing thyroidectomy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01868750.
PRIMARY OBJECTIVES:
I. To estimate effect of pre‐operative vitamin D supplementation on post-thyroidectomy serum calcium levels.
SECONDARY OBJECTIVES:
I. To evaluate the effects of pre‐operative vitamin D supplementation on the extent of post‐thyroidectomy transient hypocalcemia by assessing symptomatology, requirements for intravenous (IV) calcium and prolonged hospitalization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive calcitriol orally (PO) twice daily (BID) on days -7 to -1 prior to thyroidectomy on day 0.
ARM II: Patients receive placebo PO BID on days -7 to -1 prior to thyroidectomy on day 0.
In both arms, treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up for 2-5 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorDavid Shonka
