Vitamin D to Improve Outcomes by Leveraging Early Treatment

Vitamin D deficiency is a common, potentially reversible contributor to morbidity and
mortality among critically ill patients. We conducted a randomized, double-blind,
placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill,
vitamin D-deficient patients who were at high risk for death. Patients screened as vitamin D
deficient (<20 ng/mL) were randomized. Randomization occurred within 12 hours after the
decision to admit the patient to an intensive care unit. Eligible patients received a single
enteral dose of 540,000 IU of vitamin D3 or matched placebo. The primary end point was 90-day
all-cause, all-location mortality.

维生素D缺乏是重症患者中常见且可潜在逆转的发病与死亡风险因素。本研究针对存在死亡高风险的重症维生素D缺乏患者，开展了早期补充维生素D3的随机、双盲、安慰剂对照Ⅲ期临床试验。经筛查确诊为维生素D缺乏（<20 ng/mL）的患者将被随机分组。随机分组操作需在患者被决定收入重症监护病房后的12小时内完成。符合入组标准的患者将接受单次肠内给药，剂量为540,000 IU的维生素D3或匹配的安慰剂。本试验的主要终点为90天全因、全场所死亡率。