Back to resultsPreoperative Vitamin D for Post-thyroidectomy Hypocalcemia
Primary Purpose
Hypocalcemia
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypocalcemia focused on measuring Permanent, temporary, hypocalcemia
Eligibility 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
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Treatment
Arm Description
Pre-operative Vitamin D 800 units x 4 weeks
Outcomes
Primary Outcome Measures
Hypocalcemia
Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa < 0.9) Need for IV calcium supplementation
Secondary Outcome Measures
Hypocalcemia
ICa at 6 weeks and need for continued supplementation beyond 6 weeks post-op (i.e. 3 months follow-up post-operatively)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01609439
Brief Title
Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia
Official Title
Pre-operative Vitamin D Supplementation to Reduce Post-operative Hypocalcemia in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia
Keywords
Permanent, temporary, hypocalcemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Pre-operative Vitamin D 800 units x 4 weeks
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D 800 units for 4 weeks preoperatively
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Hypocalcemia
Description
Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa < 0.9) Need for IV calcium supplementation
Time Frame
Transient (<72 hrs post-operatively)
Secondary Outcome Measure Information:
Title
Hypocalcemia
Description
ICa at 6 weeks and need for continued supplementation beyond 6 weeks post-op (i.e. 3 months follow-up post-operatively)
Time Frame
Permanent (>4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia
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