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Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Caroline Xu, University of Alberta Identifier:
First received: May 24, 2012
Last updated: September 14, 2016
Last verified: May 2012
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.

Condition Intervention
Drug: Vitamin D
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pre-operative Vitamin D Supplementation to Reduce Post-operative Hypocalcemia in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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)

Enrollment: 0
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Treatment
Pre-operative Vitamin D 800 units x 4 weeks
Drug: Vitamin D
Vitamin D 800 units for 4 weeks preoperatively


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01609439

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
  More Information

Responsible Party: Caroline Xu, Resident, Otolaryngology-Head and Neck Surgery, University of Alberta Identifier: NCT01609439     History of Changes
Other Study ID Numbers: UAH-Oto-TT01 
Study First Received: May 24, 2012
Last Updated: September 14, 2016
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:

Additional relevant MeSH terms:
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on October 28, 2016