Protocol summary

Summary
This is a 4 week randomized controlled clinical trial investigating the adjuvant effect of diet recommendation with methylphenidate for treating 80 children with ADHD. Children will be assessed two time including at baseline and the week 4 using a DSM-IV ADHD checklist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201311303930N29
Registration date: 2013-12-22, 1392/10/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-22, 1392/10/01
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciecnes
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dietary intervention for treating ADHD, a randomized controlled clinical trial
Public title
Dietary intervention for treating ADHD, a randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children aged between 5 to 18 years old diagnosed with ADHD according to DSM-IV diagnostic criteria. Exclusion criteria: lack of providing written informed consent; serious uncontrolled medical condition such as hypothyroidism, serious interaction of recommended diet with a medical condition or methylphenidate.
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciecnes
Street address
Shiraz University of Medical Sceinces
City
Shiraz
Postal code
--
Approval date
2013-09-22, 1392/06/31
Ethics committee reference number
CP-P-92-6001

Health conditions studied

1

Description of health condition studied
Hyperkinetic disorders- Attention deficite Hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Hyperkinetic disorders

Primary outcomes

1

Description
ADHD Rating Scale
Timepoint
baseline and week 4
Method of measurement
Interveiwe

Secondary outcomes

empty

Intervention groups

1

Description
recommendation to reduce sugure intake for one month
Category
Behavior

2

Description
Control - without diet recommendation
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
Hafez Hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical sciences
Full name of responsible person
Behzad Hadad
Position
Medicine Student
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
behzad.haddad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
ghanizadeha@hotmail.com
Web page address

Person responsible for updating data

Contact

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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