Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

Not Applicable

Withdrawn

• Conditions: Hypocalcemia
• Interventions: Drug: Placebo; Drug: Vitamin D

• Registration Number: NCT01609439
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-06-01
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Treatment	Vitamin D	Pre-operative Vitamin D 800 units x 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada