Vitamin D replenishment does not benefit critical neurology patients: Clinical trial
Vitamin D replenishment in neurocritical care patients who are vitamin deficient does not show improvement finds a Clinical trial. The findings of the clinical trial have appeared in the Journal of Neurosurgery.
Vitamin D deficiency is prevalent in neurocritical care patients, but the potential to improve patient outcome by replenishing vitamin D has not been investigated. This single-centre, 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.
In the clinical trial Dr Karsy M at Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah and colleagues emergently admitted neurocritical care patients with vitamin D deficiency (≤ 20 ng/ml) from October 2016 until April 2018 who were randomized to receive vitamin D (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) length of stay, repeat vitamin D levels, patient complications, and patient disposition. The exploratory analysis evaluated specific subgroups of patients by LOS, Glasgow Coma Scale (GCS) score, and Simplified Acute Physiology Score (SAPS II).
The researchers randomized two-hundred seventy-four patients and 267 were administered treatment within 48 hours of admission (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 LOS (10.4 ± 14.5 days vs 9.1 ± 7.9 days, p = 0.4; mean difference 1.3, 95% CI -1.5 to 4.1) or ICU LOS (5.8 ± 7.5 days vs 5.4 ± 6.4 days, p = 0.4; mean difference 0.4, 95% CI -1.3 to 2.1) was seen between vitamin D3 and placebo groups, respectively. Vitamin D3 supplementation significantly improved repeat serum levels compared with placebo (20.8 ± 9.3 ng/ml vs 12.8 ± 4.8 ng/ml, p < 0.001) without adverse side effects. No subgroups were identified by the exclusion of LOS outliers or segregation by GCS score, SAPS II, or severe vitamin D deficiency (≤ 10 ng/ml).
The researchers concluded that despite studies showing that 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.Clinical trial registration no.: NCT02881957 (clinicaltrials.gov).
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