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Hypovitaminosis D in Neurocritical Patients

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status and phase

Completed
Phase 3
Phase 2

Conditions

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

Treatments

Other: Placebo
Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT02881957
IRB_00091541

Details and patient eligibility

About

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.

Full description

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.

Enrollment

274 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

274 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Placebo control (simple oral syrup)
Treatment:
Other: Placebo
Vitamin D3
Experimental group
Description:
Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)
Treatment:
Drug: Cholecalciferol

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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