Clinical trial · Interventional
Hypovitaminosis D in Neurocritical Patients
Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Craniocerebral Trauma | — | UNRESOLVED | — |
| Critical Illness | — | UNRESOLVED | — |
| Intracranial Aneurysm | — | UNRESOLVED | — |
| Intracranial Hemorrhages | — | UNRESOLVED | — |
| Meningitis | — | UNRESOLVED | — |
| Seizures | — | UNRESOLVED | — |
| Spinal Cord Injuries | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholecalciferol | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Placebo control (simple oral syrup)
- interventionNames
- Other: Placebo
- type
- EXPERIMENTAL
- label
- Vitamin D3
- description
- Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)
- interventionNames
- Drug: Cholecalciferol
Primary outcomes (2)
- measure
- Intent-to-treat Hospital Length-of-stay
- timeFrame
- Until discharge
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDGuan 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
- BACKGROUNDCarter 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
- RESULTKarsy 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