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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This study has been withdrawn prior to enrollment.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
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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 Caroline Xu, University of Alberta:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 0
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609439


Locations
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
ClinicalTrials.gov Identifier: NCT01609439     History of Changes
Other Study ID Numbers: UAH-Oto-TT01
First Submitted: May 24, 2012
First Posted: June 1, 2012
Last Update Posted: September 16, 2016
Last Verified: May 2012

Keywords provided by Caroline Xu, University of Alberta:
Permanent
temporary
hypocalcemia

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