Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

NCT ID: NCT01609439

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Hypocalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Treatment

Pre-operative Vitamin D 800 units x 4 weeks

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Vitamin D 800 units for 4 weeks preoperatively

Interventions

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Vitamin D

Vitamin D 800 units for 4 weeks preoperatively

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Caroline Xu

Resident, Otolaryngology-Head and Neck Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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UAH-Oto-TT01

Identifier Type: -

Identifier Source: org_study_id

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