Clincosm LogoSign in Get a demo

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

Sponsor
David Shonka, MD (Other)
Overall Status
Completed
CT.gov ID
NCT01868750
Collaborator
(none)
67
Enrollment
1
Location
2
Arms
98.2
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Calcitriol
  • Dietary Supplement: Control Pill
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
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 Start Date :
May 1, 2013
Actual Primary Completion Date :
Jul 8, 2021
Actual Study Completion Date :
Jul 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vitamin D (Calcitriol)

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

Dietary Supplement: Calcitriol
1.0ug twice daily for 7 days before surgery
Placebo Comparator: Control

Placebo pill taken twice daily for 7 days prior to surgery

Dietary Supplement: Control Pill
placebo pill taken twice daily for 7 days before surgery

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Evidence of Hypocalcemia [2-5 days after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Charlottesville Virginia United States 22908

Sponsors and Collaborators

  • David Shonka, MD

Investigators

  • Principal Investigator: David C Shonka, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Shonka, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier:
NCT01868750
Other Study ID Numbers:
  • 16544
First Posted:
Jun 4, 2013
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:
Thyroid Nodule
Hypocalcemia
Calcitriol

Study Results

No Results Posted as of Oct 12, 2021