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Completed

NCT Number: NCT01868750

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcitriol

Dietary Supplement

1.0ug twice daily for 7 days before surgery

Control Pill

Dietary Supplement

placebo pill taken twice daily for 7 days before surgery

Primary outcomes

  1. Measure of Serum Calcium Levels

    Time frame: 2-5 days after surgery

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

Secondary outcomes

  1. Evidence of Hypocalcemia

    Time frame: 2-5 days after surgery

    Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay

Sponsors and collaborators

Lead sponsor

David Shonka, MD

Other

Registry information

Official study title

A Phase 2, Placebo-controlled, Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidectomy

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2013
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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