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
Information provided by (Responsible Party):
Caroline Xu, University of Alberta Identifier:
First received: May 24, 2012
Last updated: May 29, 2012
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)

Estimated Enrollment: 110
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01609439

Contact: Caroline C Xu, MD 7809694655

Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Caroline C Xu, MD    7809694655   
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

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: May 29, 2012
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
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 08, 2015