Author/Authors :
FALLAH, Razieh Department of Pediatrics - Growth Disorders of Children Research Center - Shahid Sadoughi University of Medical Sciences, Yazd, Iran , SARRAF YAZD, Saeedreza Department of Clinical Pharmacology - Faculty of Pharmacy - Shahid Sadoughi University of Medical Sciences, Yazd, Iran , SOHREVARDI, Mojtaba Department of Clinical Pharmacology - Faculty of Pharmacy - Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Abstract :
Objective
Topiramate is effective in the prevention of pediatric migraine, and
studies show that vitamin D3 supplementation might also be useful
in the treatment of adult migraineurs with a normal vitamin D3 level.
The present study aimed at comparing the efficacy and safety of
topiramate plus vitamin D3 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 D3 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
D3 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 D3 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 D3
groups, respectively (P=0.8).
Conclusion
A combination of Topiramate and vitamin D3 might be considered
safe and more effective than Topiramate alone in the prophylaxis of
pediatric migraine
Keywords :
Migraine , Child , Prophylaxis , Vitamin D3 , Topiramate
