At a glance
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Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit
In Brief
A Phase 3 clinical trial evaluating Cholecalciferol and Placebo for Craniocerebral Trauma and 9 related conditions. Completed, enrolled 274 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Oral syrup placebo