We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01868750
First Posted: June 4, 2013
Last Update Posted: December 5, 2017
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.
Information provided by (Responsible Party):
David Shonka, MD, University of Virginia
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by David Shonka, MD, University of Virginia:

Primary Outcome Measures:
  • 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:
  • Evidence of Hypocalcemia [ Time Frame: 2-5 days after surgery ]
    Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay


Estimated Enrollment: 67
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01868750


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

Responsible Party: David Shonka, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01868750     History of Changes
Other Study ID Numbers: 16544
First Submitted: May 30, 2013
First Posted: June 4, 2013
Last Update Posted: December 5, 2017
Last Verified: December 2017

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