Hypovitaminosis D in Neurocritical Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Brain Cancer, Cardiology, Infectious Disease, Hospital, Hospital, Hospital, Neurology, Orthopedic, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Immunology / Infectious Diseases, Neurology, Oncology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2018 |
| Start Date: | October 10, 2016 |
| End Date: | October 10, 2018 |
Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit
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.
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.
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.
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.
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
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