Study design: Randomized, double-blind, placebo-controlled, single-center
Study: Randomized clinical trial
The sample number and sampling (Sampling): the target population of children with ADHD will be between 2 to 18 years.random sampling will be simple (Simple Random Sampling), which will be achieved through the generation of random numbers by computer.The number of samples calculated in 100 patients (50 in each group) will be. After sampling, by applying the inclusion and exclusion criteria from the study patients will be enrolled.
Inclusion: children age between 2-18 years
Exclusion: anticonvulsant, corticosteroids, supplements which contains vitamin D consumption.
chronic disease. lower than normal range of ferritine.
Blood samples taken from children with adhd diagnosed by child psychiatrist and vitamin D will be checked,we choose the people who are vitamin D deficient and randomly divided into two groups of test and control. 6Perl of vitamin D 50 000 IU given to test group and the control group will receive a placebo weekly for six weeks.After eight weeks of the study, vitamin D levels in all patients will be checked and the respond to the treatment of ADHD will be assessed by a child psychiatrist.
Intervention time: about one year 2016.07.10 to 2017.07.11
The primary outcome of the study: vitamin D levels and response to treatment of ADHD out under the supervision of physician
self-report questionnaire to evaluate the severity of symptoms of attention deficit hyperactivity Connors and recovery or non-recovery by the doctor
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012826998N2
Registration date:2017-03-01, 1395/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Saba Ghaffary
Name of organization / entity
Faculty of Pharmacy, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33266042
Email address
ghaffarys@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug Applied Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2017-07-11, 1396/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D deficiency treatment on children with Attention deficit hyperactivity disorder
(ADHD)
Public title
Effect of vitamin D deficiency treatment on children with Attention deficit hyperactivity disorder
(ADHD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: children age between 2-18 years
Exclusion:
anticonvulsant, corticosteroids, supplements which contains vitamin D consumption
chronic disease
Age
From 2 years old to 18 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
Tabriz University of Medical Sciences
Street address
Ethic department, education building, Tabriz University Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.TBZMED.REC.1395.556
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder (ADHD)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Vitamin D level
Timepoint
8 weeks
Method of measurement
blood sample
Secondary outcomes
1
Description
Factors related to severity of ADHD
Timepoint
8 weeks
Method of measurement
Coners checklist
Intervention groups
1
Description
In intervention group, 50000 IU pearl of vitamin D administered weekly for six weeks. The serum levels of vitamin D are evaluated at baseline and after eight weeks. The ADHD development is assessed by pediatrics psychologist at baseline and after eight weeks.
Category
Treatment - Drugs
2
Description
In intervention group, 50000 IU pearl of vitamin D placebo administered weekly for six weeks. The serum levels of vitamin D are evaluated at baseline and after eight weeks. The ADHD development is assessed by pediatrics psychologist at baseline and after eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykhoraeis clinic
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug Applied Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street,Tabriz , Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center, 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
Saba Ghaffary
Position
Assistant Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of pharmacy, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3336 5010
Fax
Email
ghaffarys@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
Saba Ghaffary
Position
Assistant Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
faculty of pharmacy, Assistant Professor of Clinical Pharmacy
City
Tabriz
Postal code
Phone
+41 33365010
Fax
Email
ghaffarys@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
Saba Ghaffary
Position
Assistant Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Tabriz, daneshgah street, Tabriz University of Medical Sciences
City
tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)