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Comparison of neurofeedback, vitamin D3 and combined neurofeedback with vitamin D3 supplementation in children with ADHD: a randomized, double blind, Parallel-Group trial

Protocol summary

Study aim
The aim of this study is comparison of neurofeedback, vitamin D3 and combined neurofeedback with vitamin D3 supplementation in children with ADHD.
Design
This stydy is a randomized, double -blind, with parallel groups clinical trial. 90 patients with Attention-Deficit- Hyperactivity Disorder in four groups of 30 people in a phase III trial are assigned randomly.
Settings and conduct
Location is Fetros Comprehensive Health Center.120 patients are selected. 30 patients in control group, 30 patients in neurofeedback, 30 patients in vitamin D3 and 30 patients in combined neurofeedback and vitamin D3 are assigned randomly. In this double-blind study, the psychiatrist and data analyser were kept blind to the treatment. participants pick up envelopes inside the box randomly which are in an unspecified wrapper.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of attention-deficit-hyperactivity disorder based on diagnostic and Statistical Manual of Mental Disorders (DSM), No use of Vitamin D3 before the study, Lack of any psychotherapy during last 2 months, Insufficiency 12 to 20 ng/mL (30 to 50 nmol/L) or Deficiency < 12 ng/mL (< 30 nmol/L). Exclusion criteria: Parent's dissatisfaction to participate in study, Psychiatric comorbidities (except for oppositional defiant disorder), seizure, Systolic blood pressure over 12, Drug allergy
Intervention groups
Control group:Patients do not receive intervention during the 12 weeks. Intervention group1: Patients receive 1 30-minute neurofeedback training session every week for 12 weeks. Intervention group2: Patients take vitamin Pills (50,000 IU) weekly for 12 weeks. Intervention group2: Patients receive vitamin D3 Pills (50,000 IU) weekly in addition 30-minute neurofeedback training session during 12 weeks.
Main outcome variables
Hyperactivity symptoms, Attention deficit symptomd, impulsivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190602043790N1
Registration date: 2020-06-06, 1399/03/17
Registration timing: prospective

Last update: 2020-06-06, 1399/03/17
Update count: 0
Registration date
2020-06-06, 1399/03/17
Registrant information
Name
Saba Hasanvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3324 2643
Email address
s.hasanvandi@alzahra.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neurofeedback, vitamin D3 and combined neurofeedback with vitamin D3 supplementation in children with ADHD: a randomized, double blind, Parallel-Group trial
Public title
Comparison of neurofeedback, vitamin D3 and combined neurofeedback with vitamin D3 supplementation in children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of attention-deficit-hyperactivity disorder based on diagnostic and Statistical Manual of Mental Disorders (DSM) No use of Vitamin D3 before the study Lack of any psychotherapy during last 2 months Insufficiency 12 to 20 ng/mL (30 to 50 nmol/L) or Deficiency < 12 ng/mL (< 30 nmol/L).
Exclusion criteria:
Parent's dissatisfaction to participate in study Psychiatric comorbidities (except for oppositional defiant disorder) seizure Systolic blood pressure over 12 Drug allergy
Age
From 5 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is randomly blocks A, B, C, D. Patients fall into four categories, A, B, C or D depending on the order in which they study. Block A is the control group, Block B is neurofeedback, Block C vitamin D treatment and Block D combined neurofeedback and citamin D. Random allocation is done by the researcher and the clinical caregiver and data analyzer are not aware of the allocation of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatment allocation was concealed from the psychiatrist and the data analyser who rated patients by using successively numbered, opaque, and sealed envelopes. participants pick up envelopes inside the box randomly which are in an unspecified wrapper. They are aware which experimental group they were assigned to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Science
Street address
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.BMSU.BAQ.REC.1398.026

Health conditions studied

1

Description of health condition studied
Attention-Deficit Hyperactivity Disorder
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type

Primary outcomes

1

Description
Hyperactivity symptoms
Timepoint
Assessment of ADHD - attention deficit at the beginning of the study (before the intervention), weeks 4, 8 and 12 after the start of neurofeedback in intervention groups 2 and 4 and vitamin D3 consumption in intervention groups 3 and 4.
Method of measurement
Parent and Teacher ADHD-RS-IV

2

Description
Attention-Deficit symptoms
Timepoint
Assessment of ADHD - attention deficit at the beginning of the study (before the intervention), weeks 4, 8 and 12 after the start of neurofeedback in intervention groups 2 and 4 and vitamin D3 consumption in intervention groups 3 and 4.
Method of measurement
Parent and Teacher ADHD-RS-IV

3

Description
Impulsivity
Timepoint
Assessment of ADHD - attention deficit at the beginning of the study (before the intervention), weeks 4, 8 and 12 after the start of neurofeedback in intervention groups 2 and 4 and vitamin D3 consumption in intervention groups 3 and 4.
Method of measurement
Parent and Teacher ADHD-RS-IV

Secondary outcomes

empty

Intervention groups

1

Description
Control group:Patients do not receive any intervention during the 12 weeks.
Category
Behavior

2

Description
Intervention group: Patients receive 1 30-minute neurofeedback training session every week for 12 weeks.
Category
Treatment - Devices

3

Description
Intervention group: Patients take vitamin Pills (50,000 IU) weekly (manufactured by Poursina Pharmaceuticals) on a weekly basis for 12 weeks, depending on their weight.
Category
Treatment - Drugs

4

Description
Intervention group:Patients receive vitamin Pills (50,000 IU) weekly (manufactured by Poursina Pharmaceuticals) depending on their weight in addition 30-minute neurofeedback training session every 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fetros Urban Comprehensive Center
Full name of responsible person
Dr Gholam Hossein Alishiri
Street address
Delfani Street, Enghelab Street, Khorram abad, Lorestan, Iran.
City
Khorram Abad
Province
Lorestan
Postal code
6813954833
Phone
+98 66 3321 4550
Email
s.hasanvandi@alzahra.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Gholam Hossein Alishiri
Street address
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
s.hasanvandi@alzahra.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Saba Hasanvandi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
s.hasanvandi@alzahra.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Saba Hasnvandi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8804 0060
Email
s.hasanvandi@alzahra.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Saba Hasanvandi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8805 0436
Email
s.hasanvandi@alzahra.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to main outcome or like that , can be share.
When the data will become available and for how long
Start of access, 6 months after publishing the results
To whom data/document is available
Only people working in academic institutions could apply.
Under which criteria data/document could be used
People who are conducting clinical trials in this field could apply.
From where data/document is obtainable
By referring to the electronic address: s.hasanvandi@alzahra.ac.ir
What processes are involved for a request to access data/document
The applicant can receive information by registering the exact personal details.
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