Background:There is still a need for more studies to evaluate the role of vitamin D₃ in pediatric migraine prophylaxis. Objectives: We aimed to evaluate the effects and safety of vitamin D₃ supplementation to topiramate on pediatric migraine. Methods: A double-blinded prospective clinical trial was conducted on 5- to 14-year-old children with migraine. They were randomly assigned in a 1:1 ratio into 2 groups, one with vitamin D₃ supplementation (the supplementation group) and the other without vitamin D supplementation (the placebo group). The supplementation group received topiramate plus one 5000-IU dose of vitamin D₃ daily for 4 months. The placebo group received topiramate with a placebo capsule without any effective substances. The primary outcomes were a monthly frequency of headache attacks, a good response to intervention, and reduction in migraine severity, duration, and disability before and after treatment. Fifty-six children completed the trial. Vitamin D₃ supplementation to topiramate was more effective than the placebo group in the reduction of monthly frequency (6231.31 vs 9792.24 times, P = .01) and disability score for migraines (17 566.43 vs 25 187.65, P = .04). A good response was observed in 76.13% of patients in the vitamin D₃ supplementation group and 53.5% of patients in the placebo group, and vitamin D₃ supplementation was significantly more effective than placebo (P = .01). Side effects were observed in 13.3% and 20% of the intervention group and placebo groups, respectively, P = .5. Conclusion: Vitamin D₃ supplementation in pediatric migraine prophylaxis could be a well-tolerated, safe, and effective strategy.

背景：仍然需要更多的研究来评估维生素 D ₃在儿童偏头痛预防中的作用。目的：我们旨在评估托吡酯补充维生素 D _{3对儿童偏头痛的疗效和安全性。}方法：对 5 至 14 岁的偏头痛儿童进行了一项双盲前瞻性临床试验。他们以 1:1 的比例随机分为 2 组，一组补充维生素 D ₃（补充组），另一组不补充维生素 D（安慰剂组）。补充组接受托吡酯加一剂 5000 IU 剂量的维生素 D ₃每天4个月。安慰剂组接受托吡酯和安慰剂胶囊，不含任何有效物质。主要结果是每月头痛发作频率、对干预的良好反应以及治疗前后偏头痛严重程度、持续时间和残疾的减少。五十六名儿童完成了试验。在降低偏头痛的每月频率（6231.31 对 9792.24 次， P  = .01）和残疾评分（17 566.43 对 25 187.65，P  = .04）方面，托吡酯补充维生素 D ₃比安慰剂组更有效。在维生素 D ₃补充组 76.13% 的患者和安慰剂组 53.5% 的患者中观察到良好的反应，维生素 D ₃补充剂明显比安慰剂更有效（P  = .01）。干预组和安慰剂组分别观察到 13.3% 和 20% 的副作用，P  = .5。结论：在儿童偏头痛预防中补充维生素 D ₃可能是一种耐受性良好、安全且有效的策略。