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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.
 
ClinicalTrials.gov Identifier: NCT01868750
Recruitment Status : Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
David Shonka, MD, University of Virginia

Tracking Information
First Submitted Date  ICMJE May 30, 2013
First Posted Date  ICMJE June 4, 2013
Last Update Posted Date May 7, 2021
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
Evidence of Hypocalcemia [ Time Frame: 2-5 days after surgery ]
Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Thyroid Nodules
  • Hypocalcemia
Intervention  ICMJE
  • Dietary Supplement: Calcitriol
    1.0ug twice daily for 7 days before surgery
  • Dietary Supplement: Control Pill
    placebo pill taken twice daily for 7 days before surgery
Study Arms  ICMJE
  • Active Comparator: Vitamin D (Calcitriol)
    Calcitriol, 1.0ug twice daily for 7 days prior to surgery
    Intervention: Dietary Supplement: Calcitriol
  • Placebo Comparator: Control
    Placebo pill taken twice daily for 7 days prior to surgery
    Intervention: Dietary Supplement: Control Pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2017)
67
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2013)
53
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01868750
Other Study ID Numbers  ICMJE 16544
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Shonka, MD, University of Virginia
Study Sponsor  ICMJE David Shonka, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David C Shonka, MD University of Virginia
PRS Account University of Virginia
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP