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Evaluation of magnesium effect in treatment of migraine

Evaluation of the prophylactic effect of magnesium versus placebo in reduction of frequency, severity and duration of migraine headaches in children aging 6-18 years old

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221115056506N1
Enrollment
140
Registered
2023-02-06
Start date
2023-02-09
Completion date
Unknown
Last updated
2023-02-07

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: Intervention group: Magnesium oxide 10 mg/kg in 1 or 2 divided dose for 3 months should be used. Generic Magnesium Oxide 250 mg tablets from Jalinus pharmaceutical company are used. pa

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age from 6 to 18 years old Weight less than 90 Kg Diagnosed as migraine according to IHSC-3 criteria At least 4 migraine attacks in month or 8 days-of-headache during at least 1 month ago

Exclusion criteria

Exclusion criteria: Coexistence of another type of headache Migrainous headache in at least 15 days per month Using analgesic medications in at least 15 days per month Pregnancy or intention of pregnancy History of epilepsy or other neurological comorbidities Mental retardation defined as IQ<70 Dependency or addiction to pharmaceutical or illicit drugs Magnesium administration contraindications Renal failure History of renal stone Propranolol administration contraindications Cardiac conduction block Bradycardia History of asthma History of hypersensitivity reaction to propranolol Diabetes mellitus Liver insufficiency Myasthenia gravis Psoriasis History of using migraine prophylaxis medications in the past month History of using magnesium supplements in the past month History of psychiatric disorders including depression, mood disorders, anxiety disorders or psychotic disorders History of using anti-depressants, anti-psychotics, mood stabilizers or sedatives Anticipation of patient's poor medication compliance Illiteracy of the patient and family and, inability of filling the diary

Design outcomes

Primary

MeasureTime frame
Frequency of migraine attacks per month. Timepoint: At the beginning; then, 4 weeks later; then, 12 weeks after the initiation. Method of measurement: Direct asking of the patient in the first visit; then, using migraine diary in the following visits.

Secondary

MeasureTime frame
Severity of pain during migraine attacks. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: Wong-baker scale.;Average duration of migraine attacks per month. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: direct asking and migraine diary.;Amount of analgesic medications used. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: direct asking and migraine diary.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPegah Katibeh

Shiraz University of Medical Sciences

Pegah_katibeh@yahoo.com+98 71 3612 5849

Outcome results

None listed

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