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Hypovitaminosis D in Neurocritical Patients

NCT02881957 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2022-06-15

Study results available
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Summary

Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized clinical trials within an intensive care unit (ICU) environment. Despite these findings, there have been no studies examining the impact of hypovitaminosis D in specialized neurocritical care units (NCCU). Given the often significant differences in the management of patients in NCCU and more generalized intensive care units there is a need for further inquiries into the impact of low vitamin D levels in this specific environment. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the emergent NCCU patient population. The primary outcome will involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes, including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge, complications and quality-of-life metrics. Patients will be followed for 6 months post-discharge.

Conditions

  • Craniocerebral Trauma
  • Intracranial Aneurysm
  • Brain Neoplasms
  • Spinal Cord Injuries
  • Seizures
  • Meningitis
  • Stroke
  • Intracranial Hemorrhages
  • Critical Illness
  • Vitamin d Deficiency

Interventions

DRUG

Cholecalciferol

OTHER

Placebo

Oral syrup placebo

Sponsors & Collaborators

Principal Investigators

  • Michael Karsy, MD, PhD · University of Utah, Department of Neurosurgery, Salt Lake City, UT

  • Min S Park, MD · University of Utah, Department of Neurosurgery, Salt Lake City, UT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2018-10-10
Completion
2018-10-10

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02881957 on ClinicalTrials.gov