Evaluation of the effects of vitamin D supplementation on brain mapping in children with ADHD
Design
40 children aged 7-13 years are randomly assigned by computer random numbers in case and control groups. This intervention is parallel and double-blind.
Settings and conduct
This study is performed in Imam Hossein Psychological Center in Yazd. The subjects according to the inclusion and exclusion criteria, are entered in one of the two groups randomly. They are given vitamin D and placebo, which is olive oil. In this study, the researchers and participants are blind, which is completely identical in packaging and shape and pre-determined codes by the factory.
Participants/Inclusion and exclusion criteria
1. Being 7-13 years old
2. Resident of Yazd
3. If IQ is more than 80
4. If theta wave is more than 7 hz and beta is less than 13 hz
1. Having cognitive impairments or other psychotic illnesses
2. Starting medication for hyperactivity from last year
3. Hormonal disorders including Edison's disease, Cushing's disease, hyperparathyroidism, hypo or hyperthyroidism
4. Chronic diseases including cancer, heart disease, diabetes, stroke, fibromyalgia, kidney or liver defects, multiple sclerosis and Parkinson's
5. Being premature at birth
6. Take a multivitamin or mineral multivitamin more than twice in a month for at least 6 months in last year
7. Using vitamin D supplementation more than two pearls in the last year
8. Taking more than 2 pearls of calcium- D supplements in a week, for at least 6 months in the last year
Intervention groups
Prescribing one vitamin D perl every week for 8 weeks to intervention group and one placebo perl contains olive oil every week to control group.
Main outcome variables
Vitamin D, Ca, P, brain map
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200922048802N1
Registration date:2020-11-05, 1399/08/15
Registration timing:registered_while_recruiting
Last update:2020-11-05, 1399/08/15
Update count:1
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
Hadis Hooshmandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
hadis.july.1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-05, 1399/07/14
Expected recruitment end date
2020-12-04, 1399/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of vitamin D supplementation on vitamin status and brain mapping in children with ADHD
Public title
Evaluation of the effects of vitamin D brain mapping in children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
7-13 years
IQ more than 80
Resident of Yazd
Increase theta wave above 7 hz and decrease beta below 13 hz
Exclusion criteria:
Age
From 7 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Simple Random unit: Individual Tool: Randomized Tables A balanced block method is used to allocate concealment so that the number of samples assigned to each of the groups is equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements of vitamin D and placebo in the same capsules in terms of size, color and shape Encodes A and B on supplements and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Yazd - Alam Square - Anonymous Martyrs Boulevard - Campus of Shahid Sadoughi University of Medical Sciences Yazd - School of Health
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.SSU.SPH.REC.1395.97
Health conditions studied
1
Description of health condition studied
Attention-deficit hyperactivity disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Brain map
Timepoint
Befor and after 8 weeks treatment
Method of measurement
Brain mapping
2
Description
Vitamin D
Timepoint
Befor and after 8 weeks treatment
Method of measurement
Using ELISA
Secondary outcomes
1
Description
weight
Timepoint
Befor and after 8 weeks treatment
Method of measurement
Scale
Intervention groups
1
Description
The intervention group consumes a 50,000 IU pearl of vitamin D belonging to Zahravi Company every week for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: They consume one pearl of olive oil every week, which is quite similar to the pearl of vitamin D, for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Psychological Center of Yazd
Full name of responsible person
seyed Hamid Mirhoseini
Street address
Yazd, Shahid Beheshti Boulevard, in front of the Martyr and Veterans Foundation
City
Yazd
Province
Yazd
Postal code
8917836820
Phone
+98 35 3724 0049
Email
mirhoseini.h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Najarzadeh
Street address
Yazd, Imam Hossein Square, Daneshjoo Blvd., Imam Reza Educational and Research Complex, Faculty of Health, First Floor, Nutrition and Food Security Research Center
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 35 3162 4069
Fax
+98 35 3162 3855
Email
Azadehnajarzadeh@gmail.com
Web page address
https://ssu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mahdieh Hoseinzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 1900
Email
hoseinzade.mahdie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahdieh Hoseinzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
0035 38209100
Email
hoseinzade.mahdie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hadis Hooshmandi
Position
Master Student of Health Sciences in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
hadis.july.1994@gmail.com
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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available