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

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ClinicalTrials.gov Identifier: NCT01868750
Recruitment Status : Unknown
Verified August 2018 by David Shonka, MD, University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : August 31, 2018
Sponsor:
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

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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 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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, Older Adult)
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

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
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
David Shonka, MD
Investigators
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Principal Investigator: David C Shonka, MD University of Virginia
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Responsible Party: David Shonka, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01868750    
Other Study ID Numbers: 16544
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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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
Calcitriol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents