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Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

Sponsor
University of Alberta (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01609439
Collaborator
(none)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

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
  • Drug: Vitamin D
  • Drug: Placebo
 N/A

Study Design

Study Type:
Interventional
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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Hypocalcemia [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 University of Alberta Edmonton Alberta Canada T6G 2B7

Sponsors and Collaborators

  • University of Alberta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Caroline Xu, Resident, Otolaryngology-Head and Neck Surgery, University of Alberta
ClinicalTrials.gov Identifier:
NCT01609439
Other Study ID Numbers:
  • UAH-Oto-TT01
First Posted:
Jun 1, 2012
Last Update Posted:
Sep 16, 2016
Last Verified:
May 1, 2012
Keywords provided by Caroline Xu, Resident, Otolaryngology-Head and Neck Surgery, University of Alberta
Permanent
temporary
hypocalcemia
Additional relevant MeSH terms:
Hypocalcemia
Vitamin D

Study Results

No Results Posted as of Sep 16, 2016