Investigating the effects of classical ketogenic diet on lipid profile and liver function in children with drug-resistant epilepsy
Design
This study is conducted as a clinical trial. Sampling will be done on 20 children with drug-resistant epilepsy. Children who are eligible to enter the study, a ketogenic diet will be designed for them and they will be under the diet for 3 months.
Settings and conduct
Neurology Clinic of Zahra Mardani Azar Children's Hospital, Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria of the study include: age 2 to 15 years, when the patient's seizures have not been controlled using two first-line anticonvulsants for at least six months, the patient has an average of one seizure attack per month, the patient has not have chronic disorders such as liver disease or diabetes. He/she does not have a progressive neurological disease. The child's parents or caregivers have 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.
Intervention groups
Children with treatment-resistant epilepsy referred to Zahra Mardani Azar Children's Hospital, Tabriz University of Medical Sciences
Main outcome variables
A reduction of more than 50% in the number or severity of the child's seizures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240519061838N1
Registration date:2024-05-30, 1403/03/10
Registration timing:prospective
Last update:2024-05-30, 1403/03/10
Update count:0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Khatereh Rezazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 6182
Email address
rezazadekhatere@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-26, 1403/04/06
Expected recruitment end date
2024-12-26, 1403/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of the classic ketogenic diet on lipid profile and liver function in children with drug-resistant epilepsy
Public title
Examination of effects of the classic ketogenic diet on lipid profile and liver function in children with drug-resistant epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 2 years and less than 15 years
The patient's seizures have not been controlled using two first-line anticonvulsants for at least six months, and the patient has an average of one seizure per month.
Parents or caregivers should have proper training to start, continue the diet, measure urine ketones, and record information in the relevant form.
Informed consent of the patient's parents for the child's participation in the study
Exclusion criteria:
The child with liver diseases, progressive neurological disease, metabolic disorders with ammonia levels higher than normal, or other systemic diseases.
Age
From 2 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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 Science
Street address
Pediatric Health Research Center, Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Town
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Approval date
2024-05-13, 1403/02/24
Ethics committee reference number
IR.TBZMED.REC.1403.119
Health conditions studied
1
Description of health condition studied
Drug resistant epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Liver enzymes level including aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
Timepoint
Baseline and 3 months after intervention
Method of measurement
Colorimetric method
Secondary outcomes
1
Description
Triglyceride level
Timepoint
Baseline and 3 months after intervention
Method of measurement
colorimetric method
Intervention groups
1
Description
Intervention group: ketogenic diet with appropriate calories by 4:1 or 3:1 ratio
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mardani Azar Children Hospital
Full name of responsible person
Khatereh Rezazadeh
Street address
Mardani Azar Children Hospital, Mardani Azar street, Khavaran Town
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 914 163 3180
Email
rezazadekhatere@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
shahabip@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
Khatereh Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Town
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 2106
Email
rezazadekhatere@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khatereh Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Street
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 2106
Email
rezazadekhatere@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
khatereh Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Street
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 2106
Email
rezazadekhatere@gmail.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