Abstract:

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.

Key words: vitamin D₃ nano-spray, vitamin D insufficiency, 25(OH)D, child