NCT01609439

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
Last Updated

September 16, 2016

Status Verified

May 1, 2012

First QC Date

May 24, 2012

Last Update Submit

September 14, 2016

Conditions

Hypocalcemia

Keywords

Permanenttemporaryhypocalcemia

Outcome Measures

Primary Outcomes (1)

  • Hypocalcemia

    Clinical signs and symptoms(paraesthesias, etc.) OR Laboratory evidence (ICa \< 0.9) Need for IV calcium supplementation

    Transient (<72 hrs post-operatively)

Secondary Outcomes (1)

  • Hypocalcemia

    Permanent (>4 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Treatment

EXPERIMENTAL

Pre-operative Vitamin D 800 units x 4 weeks

Drug: Vitamin D

Interventions

Vitamin DDRUG

Vitamin D 800 units for 4 weeks preoperatively

Treatment
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Hypocalcemia

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Otolaryngology-Head and Neck Surgery

Study Record Dates

First Submitted

May 24, 2012

First Posted

June 1, 2012

Last Updated

September 16, 2016

Record last verified: 2012-05

Locations

CA(1)