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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01868750
Recruitment Status : Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
David Shonka, MD, University of Virginia

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Measure of Serum Calcium Levels [ Time Frame: 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 [ Time Frame: 2-5 days after surgery ]
    Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01868750

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
David Shonka, MD
Principal Investigator: David C Shonka, MD University of Virginia

Responsible Party: David Shonka, MD, Assistant Professor, University of Virginia Identifier: NCT01868750     History of Changes
Other Study ID Numbers: 16544
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

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