Trial record 5 of 21 for:    Open Studies | "Hypocalcemia"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
David Shonka, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01868750
First received: May 30, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Thyroid Nodules
Hypocalcemia
Dietary Supplement: Calcitriol
Dietary Supplement: Control Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Measure of Serum Calcium Levels [ Time Frame: 2-5 days after surgery ] [ Designated as safety issue: No ]
    Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia


Secondary Outcome Measures:
  • Evidence of Hypocalcemia [ Time Frame: 2-5 days after surgery ] [ Designated as safety issue: No ]
    Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay


Estimated Enrollment: 53
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D (Calcitriol)
Calcitriol, 1.0ug twice daily for 7 days prior to surgery
Dietary Supplement: Calcitriol
1.0ug twice daily for 7 days before surgery
Placebo Comparator: Control
Placebo pill taken twice daily for 7 days prior to surgery
Dietary Supplement: Control Pill
placebo pill taken twice daily for 7 days before surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868750

Contacts
Contact: David C Shonka, MD 434-924-1565 dcs5z@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: David C Shonka, MD         
Sub-Investigator: Mark Jameson, MD, PhD         
Sponsors and Collaborators
David Shonka, MD
Investigators
Principal Investigator: David C Shonka, MD University of Virginia
  More Information

No publications provided

Responsible Party: David Shonka, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01868750     History of Changes
Other Study ID Numbers: 16544
Study First Received: May 30, 2013
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Hypocalcemia
Thyroid Nodule
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Calcitriol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 13, 2014