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Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

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ClinicalTrials.gov Identifier: NCT01609439
Recruitment Status : Withdrawn
First Posted : June 1, 2012
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Caroline Xu, University of Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Hypocalcemia Drug: Vitamin D Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: June 1, 2012    Key Record Dates
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