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The effect of vitamin D supplementation on inflammatory cytokines (Interleukin 6, Tumor Necrosis Factor alpha), Brain-derived neurotrophic factor (BDNF), Dopamine, Serotonin, Paroxonase-1 enzyme (PON-1),Total Antioxidant Capacity (TAC), 8-Isoprostane, Soluble intercellular adhesion molecule-1(sICAM-1) and Soluble vascular cell adhesion molecule-1(sVCAM-1) in school- aged children with Attention Deficit Hyperactivity Disorder

Protocol summary

Summary
Objective: The effect of vitamin D supplementation in children with Attention Deficit Hyperactivity Disorder Study design: Randomized, double-blind, placebo-controlled, single-center, trial study (phase II) population: school-aged children (6-12 year old) with Attention Deficit Hyperactivity Disorder Main inclusion criteria: 1.Children with ADHD according to DSM-V criteria 2.Children taking Ritalin Main exclusion criteria: 1. children use other supplements except vitamin D 2. Discontinue taking Ritalin and vitamin D Sample size: 80 children Interventions: vitamin D supplementation and placebo Intervention period: 3 months outcomes: Brain-derived neurotrophic factor (BDNF), Dopamine, Serotonin, Paroxonase-1 enzyme, Total Antioxidant Capacity, 8-Isoprostane, Interleukin 6 (IL-6), Tumor Necrosis Factor alpha (TNF-a), Soluble intercellular adhesion molecule-1 (sICAM-1), Soluble vascular cell adhesion molecule-1 (sVCAM-1)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102324081N2
Registration date: 2017-07-22, 1396/04/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-22, 1396/04/31
Registrant information
Name
Niaz Mohammadzade Honarvar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4461
Email address
honarvar@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ziaeian hospital and Tehran University Of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on inflammatory cytokines (Interleukin 6, Tumor Necrosis Factor alpha), Brain-derived neurotrophic factor (BDNF), Dopamine, Serotonin, Paroxonase-1 enzyme (PON-1),Total Antioxidant Capacity (TAC), 8-Isoprostane, Soluble intercellular adhesion molecule-1(sICAM-1) and Soluble vascular cell adhesion molecule-1(sVCAM-1) in school- aged children with Attention Deficit Hyperactivity Disorder
Public title
The Effect of Vitamin D on Attention Deficit Hyperactivity Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age between 6-12 year old ; Children with ADHD according to DSM-V criteria ; Children taking Ritalin Exclusion criteria: Children use other supplements except vitamin D3 ; Discontinue taking Ritalin and vitamin D ; Medical conditions (e.g., infectious or cardiovascular diseases, diabetes ,hypertension, Hyperthyroidism, Digestive diseases, liver or kidney diseases, respiratory diseases and allergies) ; Neurological diseases such as seizures, epilepsy and ... except ADHD ; History of severe head trauma ; BMI above the 85th percentile ; Taking any medicine except Ritalin
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Tehran University Of Medical Science
Street address
Central Department of University, Ghods St., Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.TUMS.REC.1394.1719

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
Interleukin 6 (IL-6)
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA - pg/ml

2

Description
Tumor Necrosis Factor alpha (TNF-a)
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA-pg/ml

3

Description
Brain-derived neurotrophic factor (BDNF)
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA - pg/ml

4

Description
Dopamine
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA - pg/ml

5

Description
Serotonin
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA - ng/ml

6

Description
Total Antioxidant Capacity (TAC)
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA-pg/ml

7

Description
8-Isoprostan
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA-pg/ml

8

Description
Paroxonase-1(PON-1)
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA-pg/ml

9

Description
Soluble intercellular adhesion molecule-1 (sICAM-1)
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA-ng/dl

10

Description
Soluble vascular cell adhesion molecule-1 (sVCAM-1)
Timepoint
Pre-intervention/post intervention
Method of measurement
ELISA-ng/dl

Secondary outcomes

1

Description
Symptoms
Timepoint
Pre-intervention/post intervention
Method of measurement
Conner's Parent Rating Scale-Revised [S], ADHD Rating scale-IV, Parent Rating of Evening and Morning Behavior-Revised

Intervention groups

1

Description
Intervention group: vitamin D3, 25 mcg oral tablet manufactured by Jalinous, twice a day for 3 months
Category
Treatment - Drugs

2

Description
Control group: placebo, 25 mcg oral tablet manufactured by Jalinous, twice a day for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaeian hospital
Full name of responsible person
Mohammad Effatpanah
Street address
Ziaeian hospital, Abuzar Sq, 17th district, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Sixth Floor, Central Department of University, Ghods St., Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niaz Mohammadzade Honarvar
Position
PhD Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition and Dietetic, Hojat doost Alley, Naderi St, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4461
Fax
Email
honarvar@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niaz Mohammadzade Honarvar
Position
PhD Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition and Dietetic, Hojat doost Alley, Naderi St, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4461
Fax
Email
honarvar@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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