The main objective of this experimental clinical double blind study (for doctor and patients) is to investigate the effect of magnesium as well as methylphenidate supplements on the improvement of Conners questionnaire, hyperactivity, inattention and impulsivity in two groups and then comparison between them. 7-12 age children with ADHD disorders were chosen randomly considering the inclusion criteria including IQ greater than 70, without any psychology disorder and no intake of magnesium at the last two months as well as exclusion criteria such as cutting the intake of the drug, acute physical disease and dispensing of the contribution.They were divided into two 20-membered groups, A and B. Group A would take 0.5 to 1 mg/kg/day methylphenidate tablet with 10 mg/daily magnesium tablets for 8 weeks while the other group (B) would take 0.5 to 1 mg/kg/day methylphenidate tablet with placebo. Parents Conners questionnaire would be filled for all children before and at the end of the study. Changes in score of Conners' Parent Questionnaire is as primary variable of study and side effect is as secondary variable of present study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062518927N4
Registration date:2017-09-30, 1396/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-30, 1396/07/08
Registrant information
Name
Seyed Gholamreza Noorazar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 6512
Email address
noorazars@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of magnesium supplements as complementary treatment with methylphenidate in children with attention-deficit/hyperactivity disorder
Public title
Magnesium supplements treatment with methylphenidate in children with attention-deficit/hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children between 7-12 aged; ADHD diagnosis by expert pediatric psychology physician using DSM diagnosis index; No prevention for Magnesium supplements; IQ index above 70; Without other psychology disorders; No intake of Magnesium supplements since 2 months ago; Intake of methylphenidate tablet with a dose of 0.5-1 mg/kg/day as a medical treatment. Exclusion criteria:Stop the treatment by the child or parents; incorrect intake of the drug by the child; change the treatment method; Stop the treatment due to the side effects of the drug; Acute physical disease.
Age
From 7 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of Tabriz University of Medical Sciences.
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
TBZMED.REC.1394.691
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder (ADHD)
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Change in score of Conners' Parent Questionnaire
Timepoint
Beginig of study and 8 weeks later
Method of measurement
Conners' Parent Questionnaire
Secondary outcomes
1
Description
Adverse effects
Timepoint
8 weeks later
Method of measurement
Patient follow up
Intervention groups
1
Description
In intervention group: Patients will receive 0.5 to 1 mg/kg/day methylphenidate tablet with 10 mg/daily magnesium tablets for 8 weeks.
Category
Treatment - Drugs
2
Description
In control group: Patients will receive 0.5 to 1 mg/kg/day methylphenidate tablet with placebo for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bozorgmehr Child and Adolescent Psychiatric Clinic
Full name of responsible person
Seyed Gholamreza Noorazar
Street address
Bozorgmehr Child and Adolescent Psychiatric Clinic of Tabriz University of Medical Sciences, Southern Artesh Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Seyed Gholamreza Noorazar
Position
Subspecialty of Child and Adolescent Psychiatrist.
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3380 3353
Fax
Email
noorazars@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Seyed Gholamreza Noorazar
Position
Subspecialty of Child and Adolescent Psychiatrist.
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3380 3353
Fax
Email
noorazars@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Seyed Gholamreza Noorazar
Position
Subspecialty of Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3380 3353
Fax
Email
noorazars@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)