Efficacy of topiramate alone and topiramate with supplement vitamin D3 on migraine headaches in 5-15 year old migraineur children

Evaluation of efficacy of topiramate alone and topiramate with supplement vitamin D3 on monthly frequency, severity, and disability score of headaches in 5-15 year old migraineur children without vitamin D3 deficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701092639N20

Enrollment

Registered

2017-01-10

Start date

2015-12-22

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 two months. Intervention 2: One weekly 500000 unit vitamin D3 pearl from Daroupakh

Treatment - Drugs

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

One weekly 500000 unit vitamin D3 pearl from Daroupakhsh Co, Iran and tablet of 25 and 50 mg of topiramate of Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for two months

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children aged 5-15 years old; having migraine headache based on International Headache Society Criteria; having one or more headache attack per week; having moderate or severe headache disability; having normal hemoglobin level and mean corpuscular volume (hemoglobin level more than 11.5g/dl and mean corpuscular volume more than 80 fL); having sufficient vitamin D3 level ( more than 30 ng/mL); have not received vitamin D3 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 drugs usage for more than one week; allergy to topiramat or vitamin D3; vitamin D3 level more than 80 ng/mL.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Monthly frequency of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Severity of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Duration of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Pediatric Migraine Disability score. Timepoint: Before and two months after treatment. Method of measurement: Questionnaire.	—

Measure

Time frame

Monthly frequency of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Severity of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Duration of headache. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Pediatric Migraine Disability score. Timepoint: Before and two months after treatment. Method of measurement: Questionnaire.

—

Secondary

Measure	Time frame
Frequency of more than 50 % of reduction in monthly headache frequency. Timepoint: Before and two months after treatment. Method of measurement: Asking from patient.;Clinical side effects. Timepoint: Before and two 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