Phase 3
N=274
Hypovitaminosis D in Neurocritical Patients
Craniocerebral Trauma · Intracranial Aneurysm · Brain Neoplasms · Spinal Cord Injuries · Seizures
Bottom Line
View on ClinicalTrials.gov: NCT02881957 ↗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
| Outcome | Result | p-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
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.