The purpose is to investigate the effectiveness of the prescribed treatment regimen in the performance of children with autism so that treatment and support services can be started as soon as possible and improve the cognitive and developmental process of these children as much as possible. became
Design
Clinical trial on the intervention group (before and after the diet), without parallel group, not blinded, not randomized, on 30 patients.
Settings and conduct
Application of ketogenic diet to children with autism referring to neurology clinics of Azari Mardani Children's Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Children with autism
• Age 3 to 10 years
• Proper training of parents to start and continue the diet and urine ketone measurement
• Informed consent of the patient's parents for the child's participation in the study
Exclusion criteria:
• History of clinical seizures in history
• Presence of epileptiform waves in EEG
Intervention groups
Children treated with a ketogenic diet (before and after the «ketogenic diet)
Main outcome variables
Cognitive and functional evaluation before and after applying the ketogenic diet
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131012014988N9
Registration date:2024-01-05, 1402/10/15
Registration timing:registered_while_recruiting
Last update:2024-01-05, 1402/10/15
Update count:0
Registration date
2024-01-05, 1402/10/15
Registrant information
Name
Mohammad Barzegar
Name of organization / entity
Pediatric Health Research Center,Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2265
Email address
phrc_mb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ketogenic diet on function autistic children
Public title
The effect of ketogenic diet on autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 3 to 10 years
The complaint of speech delay and lack of social communication according to the points obtained: 20-8 with high risk of autism, 3-7 with moderate risk for autism in the completed Modified Checklist for Autism in Toddlers (M-CHAT) questionnaire.
The child's parents or caregivers have the appropriate training to start, continue the diet, measure urine ketones, and record information in the relevant form, and the informed consent of the patient's parents for the child's participation in the study; is.
Exclusion criteria:
History of clinical seizures in history
Presence of epileptiform waves in EEG
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave, Medicine faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5157610144
Approval date
2023-12-04, 1402/09/13
Ethics committee reference number
IR.TBZMED.REC.1402.648
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Evaluation of cognitive function
Timepoint
Before starting the diet and 3 months later
Method of measurement
Evaluation and comparison of Autism Treatment Evaluation Checklist (ATEC) score in children with autism before and after the diet
Secondary outcomes
1
Description
Evaluation and comparison of beta-hydroxybutyrate levels
Timepoint
Before starting the diet and 3 months later
Method of measurement
Serum levels of beta-hydroxybutyrate before and after applying the ketogenic diet will be assessed by a biochemistry autoanalyzer and a commercial kit using a photometric method.
Intervention groups
1
Description
In this study, children with autism will be treated with a ketogenic diet. The classic ketogenic diet is high in fat, low in carbohydrates, and moderate in protein, adjusted to a ratio of 4:1 or 3:1 (protein and carbohydrate:fat). This diet mimics the state of fasting and changes the metabolism to use fats as the main source of energy, and the catabolism of fatty acids in the liver produces ketone bodies, which causes urinary ketosis. Before starting the regimen, routine tests will be performed and serum beta-hydroxybutyrate levels will be assessed. Also, ATEC questionnaire will be filled for patients. Then the ketogenic diet will be applied to the patients. After four months, the tests will be repeated and the ATEC questionnaire will be filled.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahra Mardani Azari Children Hospital
Full name of responsible person
Dr. Mohammad Barzegar
Street address
Mardani Azari St. Khavaran Town.Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 2105
Email
mardaniazar@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Golgash St. Daneshgah St. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Barzegar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nourologist
Street address
Maryam St. Golbad St. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 2105
Email
mm_barzegar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Barzegar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Neurology
Street address
Maryam St. Golbad St. Abresan. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 914 117 0492
Email
mm_barzegar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.bita Poorshiri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Aras buildng, Tavanir Street
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 914 301 3061
Email
bpskam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available