Protocol summary

Summary
This study aimed to evaluate the Effect of magnesium and vitamin D supplementation on cognitive and behavioral function in children with ADHD. .In this double blind randomized controlled trial 64 out patients with ADHD be selected based on Inclusion criteria 1) age between 6-12 year 2) signing informed written consents to participate in the study 4) serum 25-OH-vitamin D level less than 30 ng/dl 5) serum Mg level less than 2.3 mg/dl and exclusion criteria 1) ages outside the above range 2) unwillingness to participate in the study 3) having any other chronic medical diseases 4) serum 25-OH-vitamin D level more than 30 ng/dl and serum Mg level more than 2.3 mg/dl. Then patients will be randomly assigned in 2 groups, the first group received vitamin D(50000 IU/week) plus magnesium(6 mg/day depending on weight) and the second group received placebo. The participants will be blinded to their allocations. The cognitive and behavioral function will be assessed at the base line and week 4 and 8 after the medication started. The level of 25-OH-vitamin D and Mg will be measured at the base line and week 8 after the medication started.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030326886N1
Registration date: 2016-03-24, 1395/01/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-24, 1395/01/05
Registrant information
Name
Mostafa Hemamy
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2110
Email address
mostafa.hemamy@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical science
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of supplementation with vitamin D and magnesium compared with placebo on cognitive function and behavior in children with attention deficit hyperactivity disorder
Public title
Effect of magnesium and vitamin D supplementation in the treatment of ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) age between 6-12 year 2) signing informed written consents to participate in the study 4) serum 25-OH-vitamin D level less than 30 ng/dl 5) serum Mg level less than 2.3 mg/dl. Exclusion criteria: 1) Ages outside the above range 2) Unwillingness to participate in the study 3) having chronic medical diseases 4) serum 25-OH-vitamin D level more than 30 ng/dl and serum Mg level more than 2.3 mg/dl.
Age
From 6 years old to 12 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Subjects will be assigned randomly (block randomization) in two groups. The intervention group will receive magnesium (magnesium sulfate tablet) at a dose of 6 milligram per day and vitamin D (pearl) at a dose of 50000 international unit per week for 8 week. The control group will receive placebo. Blinding: the participants are blind to their allocations

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezargerib street, Isfahan
City
Isfahan
Postal code
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.MUI.REC.1394.3.961

Health conditions studied

1

Description of health condition studied
attention deficit-hyperactivity disorder
ICD-10 code
F 90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
cognitive and behavioral function
Timepoint
before, 4 weeks and 8 weeks after intervention
Method of measurement
Conner's Parent Rating Scale (CPRS)

2

Description
cognitive and behavioral function
Timepoint
before, 4 weeks and 8 weeks after intervention
Method of measurement
Strength and Difficulties Questionnaire (SDQ)

Secondary outcomes

1

Description
Serum vitamin D level
Timepoint
First and end of intervention(2 month)
Method of measurement
ELISA

2

Description
Serum magnesium level
Timepoint
First and end of intervention(2 month)
Method of measurement
spectrophotometry

Intervention groups

1

Description
The intervention group will receive magnesium (magnesium sulfate tablet) at a dose of 6 milligram per day and vitamin D (pearl) at a dose of 50000 international unit per week
Category
Treatment - Drugs

2

Description
Control group will receive placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorshid clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
Ostandari Street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Hezargerib Street, Isfahan
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mostafa Hemamy
Position
MSc of Nutrition & Dietetics
Other areas of specialty/work
Street address
Hezargerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2110
Fax
Email
mostafahemamy@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
MD & PhD (Nutritionist)
Other areas of specialty/work
Street address
Hezargerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2110
Fax
Email
askari@mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Mostafa Hemamy
Position
MSc of Nutrition & dietetics
Other areas of specialty/work
Street address
Hezargerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 51 3211 0386
Fax
Email
mostafahemamy@yahoo.com
Web page address

Sharing plan

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