Abstract

Objective Topiramate is effective in the prevention of pediatric migraine, and studies show that vitamin D-3 supplementation might also be useful in the treatment of adult migraineurs with a normal vitamin D-3 level. The present study aimed at comparing the efficacy and safety of topiramate plus vitamin D-3 and topiramate alone in the prophylaxis of pediatric migraine. Materials & Methods In a single-blinded, randomized, clinical trial, 5-15-year-old children with migraine headaches, referred to the Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from January 2016 to January 2017, were randomly allocated to receive 2 mg/kg/day of topiramate or 2 mg/kg/day of topiramate plus one 500,000 IU vitamin D-3 pearl weekly for two consecutive months. Primary outcomes were the reduction of monthly frequency, severity, duration, and the disability score of migraine, and the secondary outcomes included a good response to treatment (more than 50 reduction in monthly headache frequency) and a lack of clinical adverse events. Results Totally, 31 female and 26 male children with the mean age of 10.02 +/- 2.11 years were evaluated. Both drugs were effective in the reduction of monthly frequency, severity, duration, and disability for headaches. Nevertheless, the combination of topiramate and vitamin D-3 was more effective than topiramate alone in reducing the monthly headaches frequency (6.12 +/- 1.26 vs. 9.87 +/- 2.44 times, P=0.01) and disability score (19.24 +/- 6.32 vs. 22.11 +/- 7.91, P=0.02). Good response to treatment was observed in 60.7 and 75.9 of the subjects in the topiramate alone and topiramate plus vitamin D-3 groups, respectively, and topiramate plus vitaminD3 was more effective (P= 0.01). Transient mild side effects were observed in 14.3 and 17.2 of the subjects in the topiramate alone and topiramate plus vitamin D-3 groups, respectively (P=0.8). Conclusion A combination of Topiramate and vitamin D-3 might be considered safe and more effective than Topiramate alone in the prophylaxis of pediatric migraine.