This study will be done to answer this question that whether supplement ferrous sulfate treatment can reduce monthly frequency, severity, and disability score of migraine headaches in migraineur children without iron deficiency. In a clinical trial, sixty 5-15 year old children with migraine headache and without iron deficiency (serum hemoglobin, iron and ferritin levels in normal limits) 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 2mg/kg/day of ferrous sulfate will be given .The drugs will be continued for three months and the children will be followed up monthly for three consecutive months. Primary outcomes include monthly frequency, severity, and duration and disability score of migraine headache that will be compared before and after three 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.