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NCT01609439 Clinical Trial

Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

Hypocalcemia Clinical Trial

Official title:
Pre-operative Vitamin D Supplementation to Reduce Post-operative Hypocalcemia in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01609439
Other study ID # UAH-Oto-TT01
Secondary ID
Status Withdrawn
Phase N/A
First received May 24, 2012
Last updated September 14, 2016

Study information
Verified date May 2012
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D
Vitamin D 800 units for 4 weeks preoperatively
• Placebo
Placebo

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypocalcemia Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa < 0.9) Need for IV calcium supplementation Transient (<72 hrs post-operatively) No
Secondary Hypocalcemia ICa at 6 weeks and need for continued supplementation beyond 6 weeks post-op (i.e. 3 months follow-up post-operatively) Permanent (>4 weeks) No
See also
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Completed NCT05043584 - Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions N/A
Recruiting NCT05885256 - Clinical Assessment of Low Calcium In traUMa (CALCIUM)
Recruiting NCT04160637 - Is There Benefit From Early Postoperative PTH Monitoring?
Completed NCT00506103 - The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study N/A
Recruiting NCT05585593 - Registry for Hypoparathyroidism Wuerzburg
Recruiting NCT04012476 - Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy Phase 4
Recruiting NCT05586529 - Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia N/A
Completed NCT01868750 - Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia Phase 2
Completed NCT00668200 - Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast® Phase 4
Terminated NCT00623974 - Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia Phase 2
Completed NCT00630214 - Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection Phase 2
Not yet recruiting NCT03685877 - Hypocalcemia in Infants and Children
Terminated NCT00001151 - Studies With 1,25-Dihydroxycholecalciferol Phase 2
Completed NCT04750460 - Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa). Phase 3
Not yet recruiting NCT03063060 - The Impact of Vitamin D Deficiency on Hypocalcaemia Following Total Thyroidectomy N/A
Not yet recruiting NCT04304573 - Is Correcting Total Serum Calcium Levels Important After Thyroidectomy
Recruiting NCT05216419 - Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy Phase 4
Recruiting NCT04775381 - Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation Phase 3
Active, not recruiting NCT01632514 - Vitamin D Deficiency and Postoperative Hypocalcemia Phase 4