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Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609439
First Posted: June 1, 2012
Last Update Posted: September 16, 2016
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):
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 ClinicalTrials.gov 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.
Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hypocalcemia
  • Drug: Vitamin D
    Vitamin D 800 units for 4 weeks preoperatively
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Treatment
    Pre-operative Vitamin D 800 units x 4 weeks
    Intervention: Drug: Vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
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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)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01609439
UAH-Oto-TT01
Yes
Not Provided
Not Provided
Caroline Xu, University of Alberta
University of Alberta
Not Provided
Not Provided
University of Alberta
May 2012

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