Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit

Principal Investigator: Michael Karsy
Keywords: Vitamin D3 , Cholecalciferol , Neurocritical care unit , Neurosurgery , Neurology , Patient outcome Department: Neurosurgery
IRB Number: 00091541 Co Investigator: Min Park
Specialty: Neurosurgery, Neurosurgery, Neurology
Sub Specialties: Trauma - Neuro Critical Care, Neuro Intensive Care
Recruitment Status: Not yet recruiting

Contact Information

Michael Karsy
michael.karsy@hsc.utah.edu
801-581-2121

Brief Summary

  1. Evaluate the impact of vitamin D supplementation on the length-of-stay of emergent neurocritical care patients (primary outcome)
  2. Evaluate the impact of vitamin D supplementation on in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge, complications, and quality-of-life metrics (secondary outcome)
  3. Evaluate the impact of vitamin D supplementation on Glasgow Outcome score and quality-of-life metrics at 3 and 6 months post-discharge (secondary outcome)

Inclusion Criteria

  • Patients >18 years of age
  • Patients admitted to the neurosurgery or neurology services
  • Patients admitted to a critical care unit
  • Informed consent
  • Expected to stay in the ICU for 48 hours or more
  • Vitamin D deficiency (<20ng/dL)

Exclusion Criteria

  • Patients where a vitamin D level was not drawn within 48 hours of admission
  • Patients not randomized within 48 hours of admission
  • Readmitted patients to the critical care unit
  • Lack of informed consent
  • Prior supplementation with vitamin D
  • Severely impaired gastrointestinal function
  • Other trial participation
  • Pregnant or lactating women
  • Hypercalcemia (total calcium of >10.6 mg/dL or ionized serum calcium of >5.4 mg/dL
  • Tuberculosis history or clinical exam
  • Sarcoidosis history or clinical exam
  • Nephrolithiasis within the prior year
  • Patients not deemed suitable for study participation (ie, psychiatric disease, living remotely from the clinic, or prisoner status)
  • Pregnant or nursing women