Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

This study is not yet open for participant recruitment.
Verified May 2012 by University of Alberta
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
  Purpose

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
Hypocalcemia
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
Placebo
Experimental: Treatment
Pre-operative Vitamin D 800 units x 4 weeks
Drug: Vitamin D
Vitamin D 800 units for 4 weeks preoperatively

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609439

Contacts
Contact: Caroline C Xu, MD 7809694655 cxu@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Caroline C Xu, MD    7809694655    cxu@ualberta.ca   
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

Responsible Party: Caroline Xu, Resident, Otolaryngology-Head and Neck Surgery, University of Alberta
ClinicalTrials.gov 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:
Permanent
temporary
hypocalcemia

Additional relevant MeSH terms:
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014