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WithdrawnNCT01609439Updated Sep 16, 2016

Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

An interventional study of Vitamin D and Placebo in Hypocalcemia, sponsored by University of Alberta. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-16.

Sponsored by University of Alberta · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypocalcemia

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Keywords

  • Permanent
  • temporary
  • hypocalcemia
03

In context

Hypocalcemia

82 studies on the registry are indexed under Hypocalcemia; 15 are open to participants now.

Browse Hypocalcemia studies →

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients undergoing total thyroidecomty +/- CND
  • Adult (age > or = 18)

Exclusion criteria

Exclusion Criteria:

  • Known chronic kidney disease
  • Known primary hyper or hypoparathyroidism
  • Known hypoalbuminemia
  • Concurrent use medications affecting calcium metabolism
  • Completion hemithyroidectomy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Treatment

    Pre-operative Vitamin D 800 units x 4 weeks

    Drug: Vitamin D

Interventions

  • DrugVitamin D

    Vitamin D 800 units for 4 weeks preoperatively

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Hypocalcemia

    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 outcomes

  1. Hypocalcemia

    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)

07

Study locations

1 site
  • University of Alberta
    Edmonton, Alberta T6G 2B7, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01609439
Lead sponsor
University of Alberta
Responsible party
Caroline Xu (Resident, Otolaryngology-Head and Neck Surgery, University of Alberta) — Principal investigator
First posted
Jun 1, 2012
Last update
Sep 16, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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