Migraine is the most frequent type of headache in children and preventive therapy is an important part of its management. It has been shown that administration of omega-3 fatty acids maybe reduces migraine headache attack frequency but because of different and not enough information especially in children, we decide to do this study. The purpose of this study is to show efficacy and safety of omega-3 fatty acid supplements in prophylaxis of migraine headache in children. In this randomized double blind clinical trial study, at least twenty four 5-14 year old children with migraine headache whom were referred to Pediatric Neurology Clinic of Besat Hospital and Imam Khomeini Clinic in Hamedan are distributed into two groups. In one group (case) tablet or syrup of valproate sodium with one omega-3 capsule contain of 1 gr fish oil will be prescribed and in other one (control) tablet or syrup of valproate sodium with one placebo capsule (without any active ingredient) will be given. Number, severity and disability grade of migraine headache and clinical general impression are to be compared before and after three months of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092914809N1
Registration date:2013-11-30, 1392/09/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-30, 1392/09/09
Registrant information
Name
Mahsha Sangestani
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0574
Email address
m.sangestani@ymail.com
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to comparison the effect of omega-3 supplements and placebo on pediatric migraine prophylaxis in children treated with valproate sodium
Public title
Effects of omega-3 supplements on prophylaxis of pediatric migraine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1.children in 5-14 years old age 2.Having migraine headache based on International Headache Society Criteria 3.Having frequent or disabling headaches that prophylactic therapy indicated in them (one or more headache attack per week or, three or more headache attacks per month or, more than one school day lost per month)
Exclusion Criteria: 1.Diagnosis changes each time during the study 2.Secondary headaches or other neurologic disorders 3.Not to use drugs correctly
Age
From 5 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Placebo capsules with the same color, package, and shape as omega-3 capsules are produced by Zahravi Pharmaceutical Company. Patients are considered in one of two groups, A or B, with simple random sampling method and the code will be assigned to each of them. The patient and physician are unaware of the contents of the medical groups. The patients will be treated by the physician and they will be followed for at least 3 months. The frequency and severity of headache will be registered. At the end of treatment and after the registration of patient information, codes will be unveiled.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Science
Street address
School of Medicine, Shahid Fahmide Blvd. Pazhuhesh Crossroad
City
Hamedan
Postal code
Approval date
2013-09-10, 1392/06/19
Ethics committee reference number
16/35/9/1693/پ/د
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
migraine
Primary outcomes
1
Description
Monthly frequency of headache
Timepoint
Before and after three months of treatment
Method of measurement
Asking from patient
2
Description
Severity of headache
Timepoint
Before and after three months of treatment
Method of measurement
Asking from patient
3
Description
Pediatric Migraine Disability Grade (pedMIDAS)
Timepoint
Before and after three months of treatment
Method of measurement
Asking from patient
4
Description
Clinical general impression
Timepoint
Before and after three months of treatment
Method of measurement
Asking from patient
Secondary outcomes
1
Description
Omega-3 side effects including gastrointestinal side effects and allergy
Timepoint
Monthly until three months of treatment
Method of measurement
Clinical exam and asking from patients
Intervention groups
1
Description
Twenty mg/kg/day valproate sodium daily in 2 divided doses with one omega-3 capsule contain of 1 gr fish oil, Produced by Zahravi Pharmaceutical Company, for 3 months (intervention)
Category
Treatment - Drugs
2
Description
Twenty mg/kg/day valproate sodium daily in 2 divided doses with one placebo capsule (as the same color, package, and shape as omega-3 capsule without any active ingredient, Produced by Zahravi Pharmaceutical Company) for 3 months (control)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Clinic
Full name of responsible person
Afshin Fayyazi
Street address
Imam Khomeini Clinic, Mirzade Eshghi St.
City
Hamedan
2
Recruitment center
Name of recruitment center
Pediatric Neurology Clinic of Besat Hospital
Full name of responsible person
Afshin Fayyazi
Street address
Besat Hospital, Shahid Motahari Blvd. Resalat Sq.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamedan University of Medical Science
Full name of responsible person
Saeed Bashiriyan
Street address
Vice Chancellor for Research and Technology, Hamedan University of Medical Science, Shahid Fahmide Blvd. Pazhuhesh Crossroad
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Hamedan University of Medical Science
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
Hamedan University of Medical Science, School of Medicine