目的 评估维生素D₃纳米喷剂在维生素D不足儿童中的吸收性和安全性。方法 纳入2023年10月至2024年9月就诊于上海儿童医学中心的维生素D不足的3~18周岁患儿47例，采用前瞻性随机非劣效性对照设计，将受试者随机分配至试验组（n=19）和对照组（n=28）。试验组接受维生素D₃纳米喷剂，对照组接受维生素D₃滴剂（胶囊型），于基线及用药第56天测量受试者的血清维生素D水平，以评估维生素D₃补充效果；检测受试者基线以及用药第56天血液肝肾功能和甲状旁腺激素水平以评估药物安全性。结果 试验组和对照组分别予维生素D₃纳米喷剂或维生素D₃滴剂56天后，两组血清维生素D水平均较基线明显改善，但两组间维生素D上升幅度差异无统计学意义（P>0.025）。用药第56天试验组的血清25-羟维生素D₃水平显著高于对照组，差异有统计学意义（P<0.025）。受试者用药56天后肝肾功能和甲状旁腺激素水平均未出现异常。结论 维生素D₃纳米喷剂对维生素D不足儿童的补充效果与维生素D₃滴剂相比无显著性差异，研究期间未报告不良反应。

Objective To evaluate the absorption and safety of vitamin D₃ nano-spray in children with vitamin D insufficiency. Methods A total of 47 children aged 3 to 18 years with vitamin D insufficiency who visited Shanghai Children's Medical Center from October 2023 to September 2024 were included and a prospective randomized non-inferiority controlled design was adopted, and the subjects were randomly assigned to the experimental group (n=19) and the control group (n=28). The experimental group received vitamin D₃ nano-spray, while the control group received vitamin D₃ drops (capsule form). The serum vitamin D levels of the subjects were measured at baseline and on the 56^th day of medication to evaluate the supplementation effect of vitamin D₃. The blood liver and kidney functions and parathyroid hormone levels of the subjects at baseline and on the 56^th day of medication were detected to evaluate the drug safety. Results After a 56-day intervention period, serum vitamin D levels in both experimental and control groups demonstrated a statistically significant improvement compared to baseline. Despite the overall improvement, the change of serum vitamin D levels was not significantly different between the two groups (P>0.05). Notably, the experimental group had significantly higher serum vitamin D₃ levels than the control group after 56 days (P<0.05). Throughout the study, no abnormalities in liver function, kidney function, and parathyroid hormone levels were observed. Conclusions The supplementation effect of vitamin D₃ nano-spray on children with insufficient vitamin D was not significantly different from that of vitamin D₃ drops. No adverse reactions were reported during the study period.