Determining and comparing the effectiveness of magnesium oxide and riboflavin on preventing migraine attacks in children referred to Imam Ali Clinic in Shahrekord
Design
A phase III randomized, single-blind, parallel-group clinical trial.
For this purpose, 70 identical cards were prepared, with the letter 'A' printed on 35 of them and the letter 'B' printed on the other 35. These cards were placed shuffled in a bag. For each patient, one card was drawn at random. The letter printed on the drawn card determined the patient's treatment group.
Settings and conduct
The study will be conducted at the Children's Clinic of Shahrekord . After patient selection, randomization and blinding will be performed using the method described above.
Participants/Inclusion and exclusion criteria
Inclusion criteria included:
Children aged 6 to 12 years with moderate to severe migraine headache with or without aura
Written informed consent to participate in the study
No use of medications that interact with magnesium oxide or riboflavin
No severe neurological disorders or epilepsy
No hepatic, renal, gastrointestinal, cardiovascular, or metabolic disorders
No history of tension headaches
No history of sensitivity to magnesium oxide or riboflavin
No history of renal failure
Exclusion criteria:
Any sensitivity to magnesium oxide or riboflavin during the study
Patient unwillingness to continue participating in the study
Intervention groups
A: Amitriptyline tablet (0.5-1 mg/kg), one tablet daily with a maximum daily dose of 50 mg.
Group B: Will be treated with Magnesium Oxide tablet (9 mg/kg once daily) + Riboflavin tablet (100 mg once daily)for 8 weeks.
Main outcome variables
Migraine headache onset time
Family history of migraine
Frequency of migraine headache attacks
Duration of each episode
Headache severity
Nausea
Vomiting
Dizziness
Migraine Disability Assessment Questionnaire (PedMIDAS)
Drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251020067696N1
Registration date:2025-11-26, 1404/09/05
Registration timing:retrospective
Last update:2025-11-26, 1404/09/05
Update count:0
Registration date
2025-11-26, 1404/09/05
Registrant information
Name
Mehran Ansarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3110 7207
Email address
ansarian.m157@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-06, 1404/08/15
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of magnesium oxide and riboflavin on the prevention of migraine attacks in children : A single-blind clinical trial study
Public title
Comparing the effectiveness of magnesium oxide and riboflavin on the prevention of migraine attacks in children
Purpose
Treatment
Inclusion/Exclusion 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:
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, 70 identical cards, 35 of which have the letter A and 35 of which have the letter B, are placed in a jumbled envelope and one card is randomly drawn for each patient. The letter on the card will indicate the patient's treatment group.
Blinding (investigator's opinion)
Single blinded
Blinding description
For this purpose, 70 identical cards, 35 of which have the letter A and 35 of which have the letter B, are placed in a jumbled envelope and one card is randomly drawn for each patient. The letter on the card will indicate the patient's treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Shahrekord University of Medical Sciences, Hajar Hospital Clinical Research
Street address
parastar st, Hajar Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817913645
Approval date
2025-01-19, 1403/10/30
Ethics committee reference number
IR.SKUMS.MED.REC.1403.103
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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 outcomes
1
Description
Time of migraine headache onsetFamily history of migraineFrequency of migraine headache attacksDuration of each episodeHeadache severityNauseaVomitingDizzinessMigraine Disability Assessment Questionnaire (PedMIDAS)Drug side effects
Timepoint
در ابتدای مطالعه (قبل از شروع مداخله) و دو ماه پس از درمان (انتهای مطالعه)
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.
Intervention groups
1
Description
Intervention group: Treatment with Magnesium Oxide tablet (9 mg/kg once daily)(39) + Riboflavin tablet (100 mg once daily)(30) for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
شهرکرد،کلینیک امام علی
Full name of responsible person
Mehran Ansarian
Street address
Nurse Street, Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817913645
Phone
+98 913 882 5092
Email
ansarian.m157@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Soleimani, Vice Chancellor for Research and Technology
Street address
Nurse Street, Hajar Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817913645
Phone
+98 913 882 5092
Email
ansarian.m57@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
mehran ansarian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Nurse Street, Hajar Hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817913645
Phone
+98 913 882 5092
Email
ansarian.m157@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehran Ansarian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 10, Amin 12 Alley, Iman Street, West Mirabd District, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817913645
Phone
+98 38 3110 7207
Fax
Email
ansarian.m157@gmai.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehran Ansarian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 10, Amin 12 Alley, Iman Street, West Mirabd District, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817913645
Phone
+98 38 3110 7207
Fax
Email
ansarian.m157@gmai.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available