1-Objectives:The aim of present study is to detrmine the effect of vitamin D supplementation on attention deficit hyperactivity disorder symptoms and stress oxidative in children.
2-Design: placebo controlled randomized clinical trial, double blind, phase III.
3-Setting and conduct: Sixty children with attention deficit hyperactivity disorder will be randomly allocated into two groups to receive daily either 2000IU vitamin D or placebo for 8 weeks. Ten mililiters of fasting blood samples will be collected at baseline and after intervention.
4-Inclusion criteria: signed parental consent form, diagnosis of attention deficit hyperactivity disorder in 6-12 year-old children by psychiatrist.
5-Exclusion criteria: any psychiatric, neurologic or systemic disorders based on history, consumption of any medicine or supplement.
6- Intervention: Both groups will take the standard medicine for this diease (Ritalin, 0.3-1 mg/kg/d). one group will take vitamin D3, 2000IU/d (plus Ritalin) and the second group will take placebo (plus Ritalin) for 8 weeks.
7- Primary Outcomes: Symptoms evaluation by parents Conner's questionnaire.
8- Other outcomes: Symptoms evaluation by morning-evening questionnaires, Assessment of serum levels of of 25-hydroxy vitamin D, Malondialdehyde and 8-hydroxydeoxy guanosine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404222394N10
Registration date:2014-08-15, 1393/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on attention deficit hyperactivity disorder symptoms and stress oxidative in children
Public title
Efficacy of vitamin D supplementation in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Signed parental (mother/father) informed consent; 6-12 years old children; Newly diagnosed attention deficit hyperactivity disorder children by child and adolescent psychiatrist; BMI percentile between 5 to 85. Exclusion criteria: History or current diagnosis of other psychiatric diseases (e.g., autism, bipolar disorder, major depression disorder, etc.) by psychiatrist; History or current diagnosis of neurological condition (e.g., epilepsy, brain tumors, etc.) by psychiatrist; History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.); History of major head trauma ; Diagnosis of Mental retardation; Any medicine administration at least 4weeks before the initiation of the study; Any vitamin D products (enriched products with vitamin D) at least 3 months before the initiation of the study; Any supplement use containing antioxidants like multivitamin, vitamin A,C,E at least 2 months before the initiation of the study.
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:
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 Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2014-04-14, 1393/01/25
Ethics committee reference number
92-02-27-23601-100469
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Symptoms of disease
Timepoint
week 0,4 and 8
Method of measurement
Parental Conners questionnaire
Secondary outcomes
1
Description
symptoms in morning and evening
Timepoint
week 0,4 , 8
Method of measurement
Morning-evening symptoms questionnaire
2
Description
adverse drug effects
Timepoint
week 4,8
Method of measurement
Adverse drug effects questionnaire
3
Description
Serum level of Malondialdehyde
Timepoint
week 0,8
Method of measurement
blood test
4
Description
Serum level of 8-hydroxydeoxyguanosine
Timepoint
week 0,8
Method of measurement
blood test
5
Description
Serum level of 25-hydroxyD
Timepoint
week 0,8
Method of measurement
blood test
Intervention groups
1
Description
intervention group: vitamin D, 2000IU, one tablet daily for 8 weeks
Category
Treatment - Drugs
2
Description
control group: placebo containing starch and lactose, one tablet daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr Mehdi Tehranidoost
Street address
Roozbeh hospital, Southern Kargar Street
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr Rozita Davari
Street address
Imam Hossein hospital, Shahid Madani Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed AliJavad Mousavi
Street address
Iran university of medical sciences, next to Milad tower, Hemmat Highway, Tehran
City
Tehran
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, Iran 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
Nutrition and dietetics faculty of Tehran university of medical sciences
Full name of responsible person
Nakisa Mohammadpour
Position
Student of Master of Art
Other areas of specialty/work
Street address
No 44, Hojatdoost alley, Naderi street, Keshavarz boulevard, Tehran
City
Tehran
Postal code
Phone
+98 21 8804 8770
Fax
Email
mohammadpour.nakisa@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Depatment of Nutrition, Faculty of public Health, Iran university of medical sciences
Full name of responsible person
Dr. Shima Jazayeri
Position
Md, Phd of nutrition
Other areas of specialty/work
Street address
Faculty of public health, Iran university of medical sciences, next to Milad tower, Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
sjazayeri@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition and dietetics faculty of Tehran University of medical sciences
Full name of responsible person
Nakisa Mohammadpour
Position
student
Other areas of specialty/work
Street address
No 44, Hojatdoost alley, Naderi street, Keshavarz boulevard, Tehran
City
Tehran
Postal code
Phone
+98 21 8804 8770
Fax
Email
mohammadpour.nakisa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)