Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia

NCT ID: NCT01868750

Last Updated: 2021-10-12

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2021-07-08

Brief Summary

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One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. Severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a few extra days in the hospital.

The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the calcium needed to make strong bones and teeth. The purpose of this study is to determine if taking vitamin D before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital stay.

Detailed Description

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Conditions

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Thyroid Nodules Hypocalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D (Calcitriol)

Calcitriol, 1.0ug twice daily for 7 days prior to surgery

Group Type ACTIVE_COMPARATOR

Calcitriol

Intervention Type DIETARY_SUPPLEMENT

1.0ug twice daily for 7 days before surgery

Control

Placebo pill taken twice daily for 7 days prior to surgery

Group Type PLACEBO_COMPARATOR

Control Pill

Intervention Type DIETARY_SUPPLEMENT

placebo pill taken twice daily for 7 days before surgery

Interventions

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Calcitriol

1.0ug twice daily for 7 days before surgery

Intervention Type DIETARY_SUPPLEMENT

Control Pill

placebo pill taken twice daily for 7 days before surgery

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patient referred for thyroidectomy
* Agreement to use contraception prior to and during the study

Exclusion Criteria

* Hypercalcemia (\>10.5mg/dL)
* Chronic kidney or parathyroid disease
* Cardiac or Central Nervous System disease
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David Shonka, MD

OTHER

Sponsor Role lead

Responsible Party

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David Shonka, MD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David C Shonka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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16544

Identifier Type: -

Identifier Source: org_study_id

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