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Comparing the effectiveness of magnesium oxide and riboflavin on the prevention of migraine attacks in children

Comparing the effectiveness of magnesium oxide and riboflavin on the prevention of migraine attacks in children : A single-blind clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251020067696N1
Enrollment
70
Registered
2025-11-26
Start date
2025-11-06
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Migraine.

Interventions

Intervention group: Treatment with Magnesium Oxide tablet (9 mg/kg once daily)(39) + Riboflavin tablet (100 mg once daily)(30) for 8 weeks..

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to 12 years with moderate to mild migraine headaches with or without aura Written informed consent to participate in the study Avoid taking medications that interact with magnesium oxide or riboflavin. No severe neurological disorders or epilepsy No hepatic, renal, gastrointestinal, cardiovascular, or metabolic disorders No tension headaches No history of sensitivity to magnesium oxide or riboflavin No renal failure

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Average duration of migraine attacks. Timepoint: At the beginning of the study (before starting the intervention) and two months after treatment (end of the study). Method of measurement: Study data will be recorded using a researcher-made checklist that includes: age, sex, body mass index, migraine with and without aura, months since migraine onset, family history of migraine, and the average severity, frequency, and duration of headaches, dizziness, migraine disability criteria, along with the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire.

Secondary

MeasureTime frame
Time of migraine headache onsetFamily history of migraineFrequency of migraine headache attacksDuration of each episodeHeadache severityNauseaVomitingDizzinessMigraine Disability Assessment Questionnaire (PedMIDAS)Drug side effects. Timepoint: ?? ?????? ?????? (??? ?? ???? ??????) ? ?? ??? ?? ?? ????? (?????? ??????). Method of measurement: Study data will be recorded using a researcher-made checklist that includes: age, sex, body mass index, migraine with and without aura, months since migraine onset, family history of migraine, and the average severity, frequency, and duration of headaches, dizziness, migraine disability criteria, along with the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmehran ansarian

Shahre-kord University of Medical Sciences

ansarian.m157@gmail.com+98 913 882 5092

Outcome results

None listed

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