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Phase 3 N=274 Randomized Quadruple-blind Treatment

Hypovitaminosis D in Neurocritical Patients

Craniocerebral Trauma · Intracranial Aneurysm · Brain Neoplasms · Spinal Cord Injuries · Seizures

Enrolled (actual)
274
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Intent-to-treat Hospital Length-of-stay — 10.9; 9.1 days — p=0.2

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Cholecalciferol (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Utah
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Intent-to-treat Hospital Length-of-stay
10.9; 9.1 0.2
PRIMARY
As-treated Hospital Length of Stay
10.4; 9.1 0.4
SECONDARY
Intent-to-treat ICU Length of Stay
6.4; 5.4 0.3
SECONDARY
As-treated ICU Length of Stay
5.8; 5.4 0.6
SECONDARY
In-hospital Mortality
11; 13 0.7
SECONDARY
Number of Participants With Study Drug Related Adverse Events
0; 0 0.99
SECONDARY
Number of Participants With Sepsis
2; 3 0.6
SECONDARY
Number of Participants With Pneumonia
16; 14 0.7
SECONDARY
Number of Participants With Urinary Tract Infection
9; 6 0.4
SECONDARY
Number of Participants With Deep Vein Thrombosis
8; 3 0.1

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.

Eligibility Criteria

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 ( 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02881957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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