Hypovitaminosis D in Neurocritical Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-10

Study Completion Date

2018-10-10

Brief Summary

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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.

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Detailed Description

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Vitamin D has been shown as an important marker of prognosis in a variety of clinical settings, including overall mortality, acute respiratory distress syndrome (ARDS), infection/sepsis, asthma, cardiovascular disease, diabetes, and pediatric/medical/surgical intensive care unit outcomes. Vitamin D not only plays a role in bone maintenance, but also a variety of extra-axial functions including immune-dysregulation and systemic inflammation. In addition, a number of randomized clinical trials support the supplementation of vitamin D as improving outcome in critical care patients. While the evaluation of vitamin D levels remains a standard-of-care at our institution, the widespread use of vitamin D monitoring and impact on neurocritical care patients remains limited. The investigators' recent prospective observational study of vitamin D levels in neurocritical patients showed that deficiency (\<20ng/dL) was highly associated with prolonged hospital stay and increased in-hospital mortality for emergent patients. Moreover, a number of limitations arise from this study due to its observational nature. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the neurocritical care patient population. Patients admitted to the neurocritical care unit for emergent cases and with vitamin D deficiency (\<20ng/dL) will undergo vitamin D serum draw on admission and be randomized to receive cholecalciferol/vitamin D3 supplementation (540,000 IU once orally) or placebo. The primary outcome measured will be hospital length-of-stay. Secondary outcomes will include length of ICU course, complications, medication adverse events, discharge Glasgow Outcome Score, in-hospital and 30-day mortality, as well as quality-of-life. Power analysis estimates 198 patients will be needed for each subgroup to determine a 2 day difference in length-of-stay, and the study plans to recruit 218 patients per treatment arm to account for dropout, which will take approximately 6-9 months to recruit. Interim analysis and safety monitoring will be performed. The investigators hypothesize that vitamin D supplementation may make a significant impact on reducing morbidity and mortality in the neurocritical care population. The possibility of reducing hospital length of stay and mortality from a simple, safe, and cost-effective intervention such as vitamin D supplementation may be a useful adjuvant treatment in the neurocritical care population.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Placebo control (simple oral syrup)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral syrup placebo

Vitamin D3

Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Interventions

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Cholecalciferol

Intervention Type DRUG

Placebo

Oral syrup placebo

Intervention Type OTHER

Other Intervention Names

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vitamin D3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No