Hypovitaminosis D in Neurocritical Patients

• Status: Completed
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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 (<20ng/mL)

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