Evaluation of Effect of Zinc plus Multivitamin in Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) Treated with Methylphenidate
Evaluation of Effect of Zinc plus Multivitamin in Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) Treated with Methylphenidate
Design
Controlled clinical trial of random intervention
Settings and conduct
Patients with Attention Deficient Hyperactivity Disorder refer to Razi Hospital
Participants/Inclusion and exclusion criteria
Patients aged 6 to 12 years old will involve after diagnosis of ADHD according to DSM-V
Intervention groups
The intervention group receives zinc plus multivitamin and methylphenidate, and the control group receives only methylphenidate for 3 months.
Main outcome variables
Appetite; Body Mass Index; Severity of symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023083N4
Registration date:2020-05-03, 1399/02/14
Registration timing:prospective
Last update:2020-05-03, 1399/02/14
Update count:0
Registration date
2020-05-03, 1399/02/14
Registrant information
Name
Haleh Rezaee
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 2250
Email address
rezaeeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of Zinc plus Multivitamin in Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) Treated with Methylphenidate
Public title
Effect of Zinc plus Multivitamin in Attention Deficit Hyperactivity Disorder
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ADHD meeting criteria according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
Stable treatment with methylphenidate
Not receiving supplement before this study
Age range 6-12 years old
Zinc deficiency
Exclusion criteria:
Receiving supplement before this study
Other psychiatric disease like autism, Chronic disease, Taking anticonvulsant
Inability to understand and sign consent
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization does by using randomized block
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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 Science
Street address
No.20, Safa St., Besaat Ave., Mirdamad
City
Tabriz
Province
East Azarbaijan
Postal code
5166956547
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.TBZMED.REC.1398.1180
Health conditions studied
1
Description of health condition studied
Attention Deficient Hyperactivity Disorder
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type
Primary outcomes
1
Description
Appetite
Timepoint
On arrival and after 2, 4, 6, 8, 12 weeks after receiving supplement
Method of measurement
Prepared appetite questionnaire
2
Description
Weight changes
Timepoint
On arrival and after 2, 4, 6, 8, 12 weeks after receiving supplement
Method of measurement
Scale
3
Description
Body Mass Index
Timepoint
On arrival and after 2, 4, 6, 8, 12 weeks after receiving supplement
Method of measurement
The body mass divided by the square of the body height
Secondary outcomes
1
Description
severity of ADHD symptoms
Timepoint
On arrival and after 2, 4, 6, 8, 12 weeks after receiving supplement
Method of measurement
Parents conners questionnaire
Intervention groups
1
Description
Intervention group: This group receives zinc plus multivitamin and methylphenidate for 3 months
Category
Treatment - Drugs
2
Description
Control group: This group receives only methylphenidate for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Clinic of Razi Hospital
Full name of responsible person
Dr Seyed Gholamreza Noorazar
Street address
Sheykh Mohammad Khiyabani Ave., Bakeri Blvd., Elgoli, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
librazi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Haleh Rezaee
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
rezaeeha@tbzmed.ac.ir
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
Dr Haleh Rezaee
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Haleh Rezaee
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Haleh Rezaee
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD