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  • The Effect of Supplementation of Vitamin D in Neurocritical Care Patients with Hypovitaminosis D: A Randomized Controlled Clinical Trial

    Final Number:

    Andrea Archambault Brock MD; Michael Karsy MD PhD MSc; Jian Guan MD; Ilyas Eli MD; Sarah Tamara Menacho MD; Min S. Park MD

    Study Design:
    Clinical Research

    Subject Category:
    Trauma and Neurocritical Care: Cranial

    Meeting: Congress of Neurological Surgeons 2019 Annual Meeting

    Introduction: Hypovitaminosis D is prevalent in neurocritical care patients, but the potential to improve patient outcome by replenishing vitamin D has not been investigated. This single-center, double-blinded, placebo-controlled, randomized (1:1) clinical trial was designed to assess the effect on patient outcome of vitamin D supplementation in neurocritical care patients with hypovitaminosis D (NCT02881957).

    Methods: From October 2016 until April 2018, emergently admitted neurocritical care patients with vitamin D deficiency (=20 ng/ml) were randomized to receive vitamin D3 (cholecalciferol, 540,000 IU) (n=134) or placebo (n=133). Hospital length of stay (LOS) was the primary outcome; secondary outcomes included intensive care unit (ICU) LOS, repeat vitamin D levels, patient complications, and patient disposition. Exploratory analysis evaluated specific subgroups of patients by LOS, Glasgow Coma Scale (GCS), and Simplified Acute Physiology Score (SAPS II).

    Results: Two-hundred seventy-four patients were randomized (intent-to-treat) and 267 were administered treatment within 48 hours (as-treated; 61.2% of planned recruitment) and monitored. The mean age of as-treated patients was 54.0±17·2 years (56.9% male, 77.2% White). After interim analysis suggested a low conditional power for outcome difference (predictive power: 0.12), the trial was halted. For as-treated patients, no significant difference in hospital (10.4±14.5 vs. 9.1±7.9 days, p=0.4; mean difference=1.3, 95% CI= -1.5, 4.1) or ICU (ICU: 5.8±7.5 vs. 5.4±6.4 days, p=0.4; mean difference=0.4, 95% CI= -1.3, 2.1) LOS was seen between vitamin D3 and placebo groups. Vitamin D3 supplementation significantly improved repeat serum levels compared with placebo (20.8±9.3 vs. 12.8±4.8 ng/ml, p<.001) without adverse side effects. No subgroups were identified by exclusion of LOS outliers or segregation by GCS score, SAPS II score, or severe vitamin D deficiency (=10 ng/ml).

    Conclusions: Despite studies showing vitamin D can predict prognosis, supplementation in vitamin D–deficient neurocritical care patients did not result in appreciable improvement in outcomes and likely does not play a role in acute clinical recovery.

    Patient Care: This research demonstrated that despite vitamin D playing a biomarker role in prognosis for neurosurgery patients, improvement of outcomes was not achieved with supplementation in an acute setting.

    Learning Objectives: By the conclusion of this session, participants should be able to 1) discuss the role of vitamin D levels in the risk stratification of neurosurgical patients, 2) discuss the role of vitamin D supplementation in improvement of outcomes for neurosurgical patients.

    References: -Guan J, Karsy M, Brock AA, Eli I, Ledyard H, Hawryluk GW, et al: 327 A Prospective Analysis of Hypovitaminosis D and Mortality in 400 Patients in the Neurocritical Care Setting. Neurosurgery 63 Suppl 1:195, 2016 -Guan J, Karsy M, Brock AA, Eli IM, Ledyard HK, Hawryluk GWJ, et al: A prospective analysis of hypovitaminosis D and mortality in 400 patients in the neurocritical care setting. J Neurosurg 127:1–7, 2017 -Guan J, Karsy M, Brock AA, Eli IM, Manton GM, Ledyard HK, et al: Vitamin D status and 3-month Glasgow Outcome Scale scores in patients in neurocritical care: prospective analysis of 497 patients. J Neurosurg 128:1635-1641, 2018 -Guan J, Karsy M, Eli I, Bisson EF, McNally S, Taussky P, et al: Increased Incidence of Hypovitaminosis D Among Patients Requiring Treatment for Cerebral Aneurysms. World Neurosurg 88:15-20, 2016

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