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

Abstract

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, doubleblinded, 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). METHOD(S): From October 2016 to 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). RESULT(S): A total of 274 patients were randomized (intent-to-treat) and 267 were administered treatment within 48 hr (as-treated; 61.2% of planned recruitment) and monitored. The mean age of as-treated patients was 54.0 +/- 17.2 yr (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 d, P = .4; mean difference = 1.3, 95% CI = -1.5, 4.1) or ICU (ICU: 5.8 +/- 7.5 vs 5.4 +/- 6.4 d, P = .4; mean difference = .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