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Preoperative Vitamin D for 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: NCT01609439
Recruitment Status : Withdrawn
First Posted : June 1, 2012
Last Update Posted : September 16, 2016
Information provided by (Responsible Party):
Caroline Xu, University of Alberta

May 24, 2012
June 1, 2012
September 16, 2016
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Hypocalcemia [ Time Frame: Transient (<72 hrs post-operatively) ]
Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa < 0.9) Need for IV calcium supplementation
Same as current
Complete list of historical versions of study NCT01609439 on Archive Site
Hypocalcemia [ Time Frame: Permanent (>4 weeks) ]
ICa at 6 weeks and need for continued supplementation beyond 6 weeks post-op (i.e. 3 months follow-up post-operatively)
Same as current
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Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia
Pre-operative Vitamin D Supplementation to Reduce Post-operative Hypocalcemia in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial
The purpose of this study is to determine if pre-operative vitamin D supplementation lowers the incidence of post-operative transient or permanent hypoparathyroidism in patients undergoing total thyroidectomy.
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Drug: Vitamin D
    Vitamin D 800 units for 4 weeks preoperatively
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Treatment
    Pre-operative Vitamin D 800 units x 4 weeks
    Intervention: Drug: Vitamin D
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • Patients undergoing total thyroidecomty +/- CND
  • Adult (age > or = 18)

Exclusion Criteria:

  • Known chronic kidney disease
  • Known primary hyper or hypoparathyroidism
  • Known hypoalbuminemia
  • Concurrent use medications affecting calcium metabolism
  • Completion hemithyroidectomy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Caroline Xu, University of Alberta
University of Alberta
Not Provided
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University of Alberta
May 2012

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