In current randomized double blinded clinical trial study on children suffering ADHD patients enrolled according to the inclusion and exclusion criteria. 60 patients aged between 7 to 12 years old with ADHD diagnosis due to DSM-IV criteria referred to subspecialty psychiatry center selected and 30 patients assigned randomly to each A and B groups. At first, demographic data and personal information form filled during and interview with parents of all participants. Children in group A received received daily methylphenidate and placebo and group B received daily methylphenidate with zinc sulfate syrup. All patients underwent treatment for 6 weeks and for all participants prior to intervention and after intervention Kanerz parents and teachers questionnaire filled after providing necessary information and final scores recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050716077N5
Registration date:2016-05-22, 1395/03/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-22, 1395/03/02
Registrant information
Name
Ali Ramouz
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3441 3895
Email address
ali.ramouz@gmail.com
Recruitment status
Recruitment complete
Funding source
Consular of research affairs, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating effect of the zinc as a supplement to methylphenidate in children suffering ADHD
Public title
Zinc supplement effect in treatment of the children with attention deficiency-hyperactivity disorder (ADHD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children aged between 7 to 12 years; ADHD diagnosis made by youth and children psychiatry subspecialist according to DSM-IV criteria and approved by K-SADS form; no prohibition to consumption of the zinc supplements such as copper consumption; IQ more than 70; without any other psychiatric disorders approved by K-SADS form; no history of zinc consumption during last two months; receiving methylphenidate tablet in 0.5 to 1 mg/kg/day doses as treatment
Exclusion criteria: cancelling participation by parents or child consciously; not consuming according to the prescription; change in treatment method; interrupting treatment due to any reason such as drug adverse effects
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Committe of Tabriz University of Medical Sciences
Street address
Research and technology department- Daneshgah Street- Tabriz
City
Tabriz
Postal code
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
TBZMED.REC.1394.1131
Health conditions studied
1
Description of health condition studied
Attention deficiency-hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Determining symptoms severity improvement in each group according to the Kanerz questionnaire scores
Timepoint
After intervention
Method of measurement
Using Kanerz parents and teachers questionnaire
Secondary outcomes
1
Description
Determining zinc supplement effect on hyperactivity score improvement in Kanerz questionnaire
Timepoint
Before intervention, after intervention
Method of measurement
Using Kanerz parents and teachers questionnaire
2
Description
Determining zinc supplement effect on inattention score improvement in Kanerz questionnaire
Timepoint
Before intervention, after intervention
Method of measurement
Using Kanerz parents and teachers questionnaire
3
Description
Determining zinc supplement effect on hyperactivity score impulsivity in Kanerz questionnaire
Timepoint
Before intervention, after intervention
Method of measurement
Using Kanerz parents and teachers questionnaire
Intervention groups
1
Description
Group B:
Methylphenidate tablet in 0.5 to 1 mg/kg/day doses accompanied by 10 milliliter zinc sulfate syrup for 6 weeks
Category
Treatment - Drugs
2
Description
Group A:
Methylphenidate tablet in 0.5 to 1 mg/kg/day doses accompanied with placebo for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children and youth psychiatry subspecialty clinic
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyed Gholamreza Nour azar
Street address
Tabriz University of Mecial 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 of 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 Nour Azar
Position
Assisstant professor of children and youth psychiatry
Other areas of specialty/work
Street address
Razi Hopital, Golshahr Street
City
Tabriz
Postal code
Phone
+98 41 3334 1705
Fax
Email
Noorazars@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr. Seyed Gholamreza Nour azar
Position
Children and youth subspecialist
Other areas of specialty/work
Street address
Razi hospital, Golshahr street
City
Tabriz
Postal code
Phone
+98 41 3334 1705
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
Ali Ramouz
Position
Medical Student
Other areas of specialty/work
Street address
Imam Reza hospital, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3441 3895
Fax
Email
ali.ramouz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)