Objective: Effectiveness of oral Vit B6 on behavioral disorders due to Phenobarbital. Design: In this interventional study, a total of 100 consenting patients will be selected and divided in to intervention and control groups using block randomization method (n=50 in each group). Proper counseling to parents patients will be done and a written informed consent will be obtained before starting the treatment regimen. Inclusion criteria: Use of phenobarbital, ages 2 to 15 years. Exclusion criteria: Another antiepileptic medication with phenobarbital. Setting and conduct: At baseline, for all patients, behavioral patterns (aggressive behavior, attention and more hyperactivity disorder) in the questionnaire containing demographic and disease information is recorded. In the intervention group, patients will be received oral Vit B6 (100 mg every 24 hours for 3 months produced by Osve CO) and oral phenobarbital (3-5 mg/kg every 24 hours for 3 months produced by Pars daroo CO). In the control group, patients will be received oral placebo (every 24 hours for 3 months produced by Osve CO) and oral phenobarbital (3- 5 mg/kg every 24 hours for 3 months produced by Pars daroo CO). After three months children's behavior will be assessed and results will be analyzed. Outcomes measure: Aggressive behavior, attention and more hyperactivity disorder.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407284676N4
Registration date:2017-06-17, 1396/03/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-17, 1396/03/27
Registrant information
Name
farzad ahmadabadi
Name of organization / entity
Ardabil University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 1322
Email address
f.ahmadabadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of oral Vit B6 on behavioral disorders due to Phenobarbital.
Public title
Effect of vitamin B6 on behavioral disorders due to Phenobarbital.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Use of phenobarbital, ages 2 to 15 years; Exclusion criteria: Another antiepileptic medication with phenobarbital
Age
From 2 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ardabil University of Medicine Sciences Ethics committee
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.ARUMS.REC.1394.5
Health conditions studied
1
Description of health condition studied
Seizure
ICD-10 code
G40
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
aggressive behavior
Timepoint
At baseline and three months after intervention
Method of measurement
Conners criteria
Secondary outcomes
1
Description
Hyperactivity disorder
Timepoint
At baseline and three months after intervention
Method of measurement
Conners criteria
2
Description
Attention
Timepoint
At baseline and three months after intervention
Method of measurement
Conners criteria
Intervention groups
1
Description
Intervention group: patients will be received oral Vit B6 (100 mg every 24 hours for 3 months produced by Osve CO) and oral phenobarbital (3-5 mg/kg every 24 hours for 3 months produced by Pars daroo CO)
Category
Treatment - Drugs
2
Description
Control group: patients will be received oral placebo (every 24 hours for 3 months produced by Osve CO) and oral phenobarbital (3- 5 mg/kg every 24 hours for 3 months produced by Pars daroo CO).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Child neurology clinic of Ardabil university of medical sciences
Full name of responsible person
Dr. Farzad Ahmadabadi
Street address
Child neurology clinic of Ardabil university of medical sciencesl, Moallem street, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr. Shahram Habibzadeh
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
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, Ardabil 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
Ardabil university of medical science
Full name of responsible person
Dr. Farzad Ahmadabadi
Position
Child neurology asisstant professor
Other areas of specialty/work
Street address
Child neurology clinic of Ardabil university of medical science, Moallem street, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3323 1322
Fax
Email
F.ahmadabadi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil university of medical science
Full name of responsible person
Dr. Farzad ahmadabadi
Position
Child neurology asisstant professor
Other areas of specialty/work
Street address
Child neurology clinic of Ardabil university of medical science, Moallem street, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1225 2252
Fax
Email
f.ahmadabadi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil university of medical science
Full name of responsible person
Dr. Farzad ahmadabadi
Position
Child neurology asisstant professor
Other areas of specialty/work
Street address
Child neurology clinic of Ardabil university of medical science, Moallem street, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3323 1322
Fax
Email
f.ahmadabadi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)