search
Back to results

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

Primary Purpose

Thyroid Nodules, Hypocalcemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcitriol
Control Pill
Sponsored by
David Shonka, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Nodules

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D (Calcitriol)

Control

Arm Description

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

Placebo pill taken twice daily for 7 days prior to surgery

Outcomes

Primary Outcome Measures

Measure of Serum Calcium Levels
Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia

Secondary Outcome Measures

Evidence of Hypocalcemia
Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay

Full Information

First Posted
May 30, 2013
Last Updated
October 8, 2021
Sponsor
David Shonka, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT01868750
Brief Title
Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Shonka, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodules, Hypocalcemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D (Calcitriol)
Arm Type
Active Comparator
Arm Description
Calcitriol, 1.0ug twice daily for 7 days prior to surgery
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo pill taken twice daily for 7 days prior to surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcitriol
Intervention Description
1.0ug twice daily for 7 days before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Pill
Intervention Description
placebo pill taken twice daily for 7 days before surgery
Primary Outcome Measure Information:
Title
Measure of Serum Calcium Levels
Description
Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia
Time Frame
2-5 days after surgery
Secondary Outcome Measure Information:
Title
Evidence of Hypocalcemia
Description
Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay
Time Frame
2-5 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Shonka, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs