This study will be done to answer this question that whether or not topiramate with supplement vitamin D3 is more efficient than topiramate alone in reduction of monthly frequency, severity, and disability score of headaches of without vitamin D3 deficiency migraineur children. In a clinical trial, sixty 5-15 year old children with migraine headache, with normal hemoglobin level and mean corpuscular volume (hemoglobin level more than 11.5g/dl and mean corpuscular volume more than 80 fL) and sufficient vitamin D3 level (more than 30 ng/mL) who would be referred to pediatric neurology clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran and prophylactic therapy would be indicated in them, will be distributed randomly into two groups. In group I, 2 mg/kg/day of topiramate and in group II, 2mg/kg/day of topiramate and one 500000 unit vitamin D3 pearl weekly will be given. The drugs will be continued for two months and the children will be followed up monthly for two consecutive months. Primary outcomes include monthly frequency, severity, duration and disability score of migraine headache that will be compared before and after two months of treatment. Severity of headache will be assessed by asking each child to grade majority of headache pain on 10-point scale as no pain = scale of 0 and the most severe pain = 10. Headaches disability will be assessed by Pediatric Migraine Disability Assessment score questionnaire. Secondary outcome include more than 50 % of reduction in monthly headache frequency and clinical side effects.
The trial uses computer generated equal simple randomization by random numbers and data collectors, outcome assessors and data analysts are kept blinded to the allocation.