Migraine is the most common cause of recurrent headache in children. According to a theory, migraine may be caused by decreased mitochondrial energy store. In this study, we will compare efficacy of high and low dose riboflavin for prophylaxis of migraine in 5-13 year-old children.In first group, 50mg riboflavin twice daily, in second group, 100mg riboflavin twice daily and in third group, placebo(neutral drug) twice daily will be prescribed for 2 months. Patients will be selected randomly in pediatric neurology clinic of Shahid Beheshti hospital and neurologic clinic of Kashan.The medications will be prescribed in all groups by double-blind method. The response will be evaluated during the last month of treatment according to decrease of headache intensity by one degree(severe to moderate or moderate to mild), decrease of headache duration and frequency(monthly attacks) by 50%.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020412361N1
Registration date:2013-03-09, 1391/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Babak Soltani
Name of organization / entity
Kasahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1557 5840
Email address
soltani_b@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-03-01, 1391/12/11
Expected recruitment end date
2014-03-02, 1392/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of riboflavin to prevent the migraine in 5-13 year-old children
Public title
The effect of riboflavin to prevent the migraine in 5-13 year-old children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 5-13 year-old migraineous children according to ICHD II criteria who have minimally two moderate to severe migraine attacks monthly.
Exclusion criteria: Epilepsy or severe neurologic disorders ; Liver, kidney, GI, metabolic or cardiovascular disorders ; Use of migraine prophylactic drugs during the last month ; Incooperation of parents or patients ; Headache attacks less than twice per month ; Tension headache ; Mild migraine headache
Age
From 5 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Kilometer Ghotbe Ravandi Bulv , Kashan University of Medical Sciences
City
Kashan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
9173
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
duration of headache
Timepoint
last month of treatment
Method of measurement
interview with parents and child
2
Description
intensity of headache
Timepoint
last month of treatment
Method of measurement
interview with parents and child
3
Description
frequency of headache attacks
Timepoint
last month of treatment
Method of measurement
interview with parents and child
Secondary outcomes
1
Description
urine color change
Timepoint
during the study weekly
Method of measurement
interview with parents and children
Intervention groups
1
Description
Interventional group1: Riboflavin 50mg BID for 2 months
Category
Prevention
2
Description
Control group: placebo(neutral drug) for 2 months
Category
Prevention
3
Description
Interventional groups2: Riboflavin 100mg BID for 2 months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Shahid Beheshti Hospital, Kashan, Iran
Full name of responsible person
Dr. Ahmad Talebian
Street address
Shahid Beheshti Hospital, 5th Kilometer Ghotbe Ravandi Bulv, Kashan, Iran
City
Kashan
2
Recruitment center
Name of recruitment center
Neurology Clinic of Kashan City, Iran
Full name of responsible person
Dr. Ahmad Talebian
Street address
Number 5 Flat, Number 25, Medical Site, Kamalolmolk Square, Kashan, Iran
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv , Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Babak Soltani
Position
Pediatric Infectious Diseases Specialist/Assistant Professor
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Bulv , Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1557 5840
Fax
Email
babak_soltani1969@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr. Ahmad Talebian
Position
Pediatric Neurologist/Professor
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Bulv , Kashan Univercity of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1534 3582
Fax
Email
talebianmd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Babak Soltani
Position
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, 5th Kilometer Ghotbe Ravandi Bulv, Iran
City
Kashan
Postal code
Phone
+98 55 75840
Fax
Email
babak_soltani1969@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)