Ferrous sulfate in migraine headaches of children

Evaluation of efficacy of topiramate and topiramate with supplement ferrous sulfate on monthly frequency, severity, and disability score of migraine headaches in 5-15 year old migraineur children without iron deficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201504042639N15

Enrollment

Registered

2015-05-06

Start date

2014-05-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine. Migraine

Interventions

Intervention 1: Tablet of 25 and 50 mg of topiramate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for three months. Intervention 2: Tablet of 25 and 50 mg of topiramate of Daroupakhsh

Treatment - Drugs

Tablet of 25 and 50 mg of topiramate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for three months

Tablet of 25 and 50 mg of topiramate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose and tablet of 50 mg ferrous sulfate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children aged 5-15 years , Having migraine headache based on International Headache Society Criteria , Having one or more headache attack per week , Having moderate or severe headache disability , Having no iron deficiency (serum hemoglobin, iron and ferritin levels in normal limits) , Have not received iron combinations within the past two months , Not used any migraine preventive therapy Exclusion criteria: Secondary headaches such as epilepsy or other neurologic disorders, Irregular drugs usage, Discontinuation of iron usage for more than one week

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Monthly frequency of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Severity of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Duration of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Pediatric Migraine Disability score. Timepoint: before and three months after treatment. Method of measurement: asking from patient.	—

Measure

Time frame

Monthly frequency of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Severity of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Duration of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Pediatric Migraine Disability score. Timepoint: before and three months after treatment. Method of measurement: asking from patient.

—

Secondary

Measure	Time frame
Side effects. Timepoint: monthly until three months after treatment. Method of measurement: clinical exam and asking from patients.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Razieh Fallah

Shahid Sadoughi University of Medical Sciences , Yazd , Iran

dr.raziehfallah@yahoo.com+98 35 3822 4000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026