We aimed to determine effects of a high protein diet on the growth of children with attention deficit hyperactivity disorder receiving Ritalin in a randomized clinical study. Fifty children aged 7 to 12 years with Attention deficit hyper activity disorder (ADHD) referring to a Psychiatric Clinic who receive Ritalin will randomly be assigned to two groups of high protein diet (35% of total calories from protein) Diet or no intervention (control group).
In the first visit after obtaining informed consent from parent and child, the child's height and weight will be recorded in standard mode.Then ADHD rating scale, and appetite questionnaire will be completed by parents with the help of the child. Then children will randomly be divided into two groups: high protein group which children will receive a high-protein diet with 35% of total calories from protein by a dietitian based on criteria such as age, height, weight, and size of children. In the control group children will not go on a diet and they only receive Ritalin by psychiatrist.
1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after baseline height and weight and appetite and attention and hyperactivity in children will be assessed. During each month intake of calories and protein in the diet and the diet adherence will be controlled by a 7-day food record.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062116465N4
Registration date:2016-01-07, 1394/10/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-07, 1394/10/17
Registrant information
Name
Seyed-Ali Mostafavi
Name of organization / entity
Psychiatry Research Center/ Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 2002
Email address
mostafavi_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a high protein diet on weight and height of children with attention deficit hyperactivity disorder receiving Ritalin
Public title
Effect of a high protein diet on the growth of hyperactive children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: children 7 to 12 years old; the diagnosis of ADHD by a psychologist based on diagnostic criteria for DSM V and KSADS interviews; receiving Ritalin by a psychiatrist; signing consent form by parents and oral assent by children
Exclusion criteria: dissatisfaction of parent or child; Protein-vitamin supplements or Appetizer medications
Age
From 7 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization using a random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research Deputy of Tehran University of Medical Sciences, Keshavarz Avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-10-10, 1394/07/18
Ethics committee reference number
IR.Tums.REC.1394.905
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder (ADHD)
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Height
Timepoint
At baseline and 1 month, 2 month, 3 month, 4 month, 5 month, and 6 month after subjects enrolment
Method of measurement
Measurement will be done using stadiometer in standard situation in cm
2
Description
Weight
Timepoint
At baseline and 1 month, 2 month, 3 month, 4 month, 5 month, and 6 month after subjects enrolment
Method of measurement
Measurement will be done using scale in standard situation in kg
Secondary outcomes
1
Description
Attention deficiency score and Hyperactivity score
Timepoint
At baseline and 1 month, 2 month, 3 month, 4 month, 5 month, and 6 month after subjects enrolment
Method of measurement
ADHD rating scale for children (complited by parents)
Intervention groups
1
Description
Intervention group: In this group a high protein diet with 35% of total calories from protein will be administered by a dietitian plus methylphenidate (Rytalyn- 1 mg per kg weight of the child)
Category
Treatment - Other
2
Description
Control group: In this group no intervention will be done on diet, but children will receive standard treatment with methylphenidate (Rytalyn- 1 mg per kg weight of the child)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mohammad Reza Mohammadi's Private clinic
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs. Karimi
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Keshavarz Avenue, Tehran
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
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed-Ali Mostafavi
Position
PhD by research student
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street , Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mostafavi.n80@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Psychiatry research center
Full name of responsible person
Seyed-Ali Mostafavi
Position
PhD by research student
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street, Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mostafavi.n80@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed-Ali Mostafavi
Position
PhD by research student
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street, Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mostafavi.n80@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)