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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2013 by University of Virginia.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
David Shonka, MD, University of Virginia Identifier:
First received: May 30, 2013
Last updated: June 19, 2013
Last verified: June 2013

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 Intervention Phase
Thyroid Nodules
Dietary Supplement: Calcitriol
Dietary Supplement: Control Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Measure of Serum Calcium Levels [ Time Frame: 2-5 days after surgery ] [ Designated as safety issue: No ]
    Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia

Secondary Outcome Measures:
  • Evidence of Hypocalcemia [ Time Frame: 2-5 days after surgery ] [ Designated as safety issue: No ]
    Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay

Estimated Enrollment: 53
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01868750

Contact: David C Shonka, MD 434-924-1565

United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: David C Shonka, MD         
Sub-Investigator: Mark Jameson, MD, PhD         
Sponsors and Collaborators
David Shonka, MD
Principal Investigator: David C Shonka, MD University of Virginia
  More Information

Responsible Party: David Shonka, MD, Assistant Professor, University of Virginia Identifier: NCT01868750     History of Changes
Other Study ID Numbers: 16544 
Study First Received: May 30, 2013
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Thyroid Nodule
Calcium Metabolism Disorders
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Metabolic Diseases
Neoplasms by Site
Thyroid Diseases
Thyroid Neoplasms
Water-Electrolyte Imbalance
Vitamin D
Bone Density Conservation Agents
Calcium Channel Agonists
Growth Substances
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasoconstrictor Agents
Vitamins processed this record on May 30, 2016