Journal of Clinical Pediatrics >
Evaluation of the absorbency and safety of vitamin D3 nano-spray in children with vitamin D insufficiency: a prospective randomized non-inferiority controlled trial
Received date: 2025-03-13
Accepted date: 2025-08-13
Online published: 2025-09-29
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 56th 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 56th 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
LI Jing , QIAO Jing , LUO Yingren , SHAN Hongmei , HONG Li , ZHANG Chengchen . Evaluation of the absorbency and safety of vitamin D3 nano-spray in children with vitamin D insufficiency: a prospective randomized non-inferiority controlled trial[J]. Journal of Clinical Pediatrics, 2025 , 43(10) : 755 -761 . DOI: 10.12372/jcp.2025.25e0226
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