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Hypovitaminosis D in Neurocritical Patients

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ClinicalTrials.gov Identifier: NCT02881957
Recruitment Status : Active, not recruiting
First Posted : August 29, 2016
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Karsy, MD, PhD, MSC, University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Craniocerebral Trauma Intracranial Aneurysm Brain Neoplasms Spinal Cord Injuries Seizures Meningitis Stroke Intracranial Hemorrhages Critical Illness Vitamin d Deficiency Drug: Cholecalciferol Other: Placebo Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit
Actual Study Start Date : October 10, 2016
Estimated Primary Completion Date : October 10, 2018
Estimated Study Completion Date : October 10, 2018


Arm Intervention/treatment
Placebo Comparator: Control
Placebo control (simple oral syrup)
Other: Placebo
Oral syrup placebo

Experimental: Vitamin D3
Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)
Drug: Cholecalciferol
Other Name: vitamin D3




Primary Outcome Measures :
  1. Hospital length-of-stay [ Time Frame: 3 days-2 months ]
    Patient length of stay from time of hospital admission to discharge


Secondary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 3 days-2 months ]
    Patient death between time of admission to discharge

  2. ICU length-of-stay [ Time Frame: 3 days-2 months ]
    Patient length of stay from time of ICU admission to transfer or discharge

  3. Glasgow Outcome Score [ Time Frame: 3 days-2 months ]
    Glasgow Outcome Score at time of discharge

  4. Hospital complications [ Time Frame: 3 days-2 months ]
    Patient complications from time of admission to discharge including sepsis/infections, deep vein thrombosis, ICU readmission, pneumonia

  5. SF-36 quality-of-life metric [ Time Frame: 3 days-2 months ]
    SF-36 quality-of-life survey prior to discharge

  6. Study drug adverse events [ Time Frame: 3 days-2 months ]
    Occurrence of Common terminology criteria for adverse events (CTCAE) grade 3 or higher specific to vitamin D from time of study drug administration to discharge

  7. Glasgow Outcome Score followup [ Time Frame: 1, 3 and 6 months post-discharge ]
    Glasgow Outcome Score at 1, 3 and 6 months post-discharge

  8. SF-36 quality-of-life metric followup [ Time Frame: 1, 3 and 6 months post-discharge ]
    SF-36 quality-of-life survey at 1, 3 and 6 months post-discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881957


Locations
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Michael Karsy, MD, PhD University of Utah, Department of Neurosurgery, Salt Lake City, UT
Study Director: Min S Park, MD University of Utah, Department of Neurosurgery, Salt Lake City, UT

Additional Information:
Publications:
Responsible Party: Michael Karsy, MD, PhD, MSC, M.D. Ph.D., University of Utah
ClinicalTrials.gov Identifier: NCT02881957     History of Changes
Other Study ID Numbers: IRB_00091541
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Karsy, MD, PhD, MSC, University of Utah:
critical illness
craniocerebral trauma
intracranial aneurysm
spinal cord injuries
seizures
meningitis
stroke
vitamin d deficiency
cholecalciferol
intracranial hemorrhages

Additional relevant MeSH terms:
Hemorrhage
Spinal Cord Injuries
Aneurysm
Seizures
Critical Illness
Meningitis
Vitamin D Deficiency
Intracranial Aneurysm
Brain Neoplasms
Intracranial Hemorrhages
Avitaminosis
Rickets
Craniocerebral Trauma
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Epilepsy
Brain Diseases
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Deficiency Diseases
Malnutrition
Nutrition Disorders
Intracranial Arterial Diseases