1. Evaluation and comparison of the frequency of migraine attacks and serum homocysteine levels in children with migraine in the vitamin and control groups.
2. Evaluation and comparison of the frequency of migraine attacks and serum homocysteine in children with migraine before and after the vitamin administration.
3. Evaluation and comparison of the frequency of migraine attacks and serum homocysteine levels in children with migraine before and after administration of placebo.
4. Evaluation of correlation between serum homocysteine and frequency of attacks in children with typical migraine in the vitamin and control (placebo) groups.
Design
A double-blind clinical trial with a age, sex, and migraine severity matched control group.
Settings and conduct
The children with migraine referred to Tabriz Children's Hospital will be studied. The patients will be divided into vitamin and control groups (placebo) in such a way that the patients, data collectors and analyzers will be blinded about the grouping.
Participants/Inclusion and exclusion criteria
90 children under the age of 12 years; with a typical migraine; after obtaining informed consent from their parents will enter the study (inclusion criteria). Patients with congenital anomalies; cardiovascular diseases; metabolic diseases will not enter the study (exclusion criteria).
Intervention groups
Patients will be divided into two age, gender and disease severity matched vitamin and control groups, 45 patients per each. Then the patients in vitamin group will receive vitamin B-complex. In the control group, the same amount of placebo (placebo) will be prescribed.
Main outcome variables
1. The serum levels of Homocysteine.
2. The Migraine severity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131012014988N6
Registration date:2018-12-21, 1397/09/30
Registration timing:prospective
Last update:2018-12-21, 1397/09/30
Update count:0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Mohammad Barzegar
Name of organization / entity
Pediatric Health Research Center,Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2265
Email address
phrc_mb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamine B-complex Suplementation on Serum Homocysteine Level and The Disease Severity in Children with Typical-Migraine
Public title
The effect of Vitamin B-Complex on Migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children under 12 years of age with typical migraine
Obtain informed consent
Has at least one migraine attack per week
One sample will be taken before the intervention and one sample will be taken after intervention from each person in each study group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, health care personnel (doctors, nurses, etc.), data collectors and data analyzers will not be informed about grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Approval date
2018-12-05, 1397/09/14
Ethics committee reference number
IR.TBZMED.REC.1397.544
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura
Primary outcomes
1
Description
Migraine Severity: The frequency of migraine attacks per week.
Timepoint
At the beginning of the study (before intervention), and 8 weeks after the intervention.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
The serum levels of Homocysteine
Timepoint
At the beginning of the study (before intervention), and 8 weeks after the intervention.
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Vitamin B-complex (Vitamix-Razak-Iran) will orally administer to intervention group. Vitamin B complex consists of several vitamins from the family of B vitamins. In this study, the prescription is given in ml, based on the instructions of the company. According to the daily requirement in this study, the dose of 1 ml/kg/day will orally administer to children for 8 weeks.
Category
Lifestyle
2
Description
Control group: a placebo of vitamin B complex (Vitamix-Razak-Iran) will be orally administer to the patients in the control group. In this study, the dose of 1 ml/kg/day will be administered orally to children for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Mohammad Barzegar
Street address
Tabriz Children Hospital, Sheshgelan Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
sina_raeisi7007@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ِDr. Abolghasem Jouyban
Street address
Research Vice-Chancellor, Tabriz University of Medical Sciences, Daneshgah Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
sina_raeisi7007@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sina Raeisi
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
sina_raeisi7007@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sina Raeisi
Position
ََAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
: Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
sina_raeisi7007@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sina Raeisi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
sina_raeisi7007@yahoo.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