Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Alberta.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Caroline Xu, University of Alberta
ClinicalTrials.gov Identifier:
NCT01609439
First received: May 24, 2012
Last updated: May 29, 2012
Last verified: May 2012

May 24, 2012
May 29, 2012
August 2012
August 2013   (final data collection date for primary outcome measure)
Hypocalcemia [ Time Frame: Transient (<72 hrs post-operatively) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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.
 
Not yet recruiting
110
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Caroline C Xu, MD 7809694655 cxu@ualberta.ca
Canada
 
NCT01609439
UAH-Oto-TT01
Yes
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