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

NCT01868750 | Completed Phase 2 DMC

• 1 other identifier: 16544
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Nodules; Hypocalcemia

Outcome Measures

Primary Outcomes (1)

• Measure of Serum Calcium Levels

  Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia

  2-5 days after surgery

Secondary Outcomes (1)

• Evidence of Hypocalcemia

  2-5 days after surgery

Study Arms (2)

Vitamin D (Calcitriol)

ACTIVE COMPARATOR

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

Dietary Supplement: Calcitriol

Control

PLACEBO COMPARATOR

Placebo pill taken twice daily for 7 days prior to surgery

Dietary Supplement: Control Pill

Interventions

Calcitriol DIETARY_SUPPLEMENT

1.0ug twice daily for 7 days before surgery

Vitamin D (Calcitriol)

Control Pill DIETARY_SUPPLEMENT

placebo pill taken twice daily for 7 days before surgery

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• David Shonka, MD: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Thyroid Nodule; Hypocalcemia

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• David C Shonka, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

US (1)