Hypovitaminosis D in Neurocritical Patients

NCT02881957 | Completed Phase 2 Results DMC

• 1 other identifier: IRB_00091541
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

critical illness; craniocerebral trauma; intracranial aneurysm; spinal cord injuries; seizures; meningitis; stroke; vitamin d deficiency; cholecalciferol; intracranial hemorrhages

Outcome Measures

Primary Outcomes (2)

• Intent-to-treat Hospital Length-of-stay

  Intent-to-treat hospital length-of-stay

  Until discharge

• As-treated Hospital Length of Stay

  Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients after randomization, factoring excluded patients (e.g., as-treated) using a p\<0.05 as significant.

  Until discharge

Secondary Outcomes (8)

• Intent-to-treat ICU Length of Stay

  Until discharge

• As-treated ICU Length of Stay

  Until discharge

• In-hospital Mortality

  Until discharge

• Number of Participants With Study Drug Related Adverse Events

  Until discharge

• Number of Participants With Sepsis

  Until discharge

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo control (simple oral syrup)

Other: Placebo

Vitamin D3

EXPERIMENTAL

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

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

Also known as: vitamin D3

Vitamin D3

Placebo OTHER

Oral syrup placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (3)

• Guan J, Karsy M, Brock AA, Eli IM, Ledyard HK, Hawryluk GWJ, Park MS. A prospective analysis of hypovitaminosis D and mortality in 400 patients in the neurocritical care setting. J Neurosurg. 2017 Jul;127(1):1-7. doi: 10.3171/2016.4.JNS16169. Epub 2016 Jul 1.

  PMID: 27367248 BACKGROUND

• Carter BS, Barker FG. Editorial. Choices in clinical trial design. J Neurosurg. 2019 Sep 13;133(4):1100-1102. doi: 10.3171/2019.7.JNS183276. Print 2020 Oct 1. No abstract available.

  PMID: 31518987 BACKGROUND

• Karsy M, Guan J, Eli I, Brock AA, Menacho ST, Park MS. The effect of supplementation of vitamin D in neurocritical care patients: RandomizEd Clinical TrIal oF hYpovitaminosis D (RECTIFY). J Neurosurg. 2019 Sep 13;133(4):1103-1112. doi: 10.3171/2018.11.JNS182713. Print 2020 Oct 1.

  PMID: 31518978 RESULT

Related Links

• University of Utah, Department of Neurosurgery

MeSH Terms

Conditions

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

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Hemorrhage; Pathologic Processes; Disease Attributes; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Michael Karsy
• Organization: University of Utah

michael.karsy@hsc.utah.edu

801-581-6908

Study Officials

• Michael Karsy, MD, PhD

  University of Utah, Department of Neurosurgery, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

• Min S Park, MD

  University of Utah, Department of Neurosurgery, Salt Lake City, UT

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: October 10, 2016
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: June 15, 2022
• Results First Posted: August 17, 2020

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)