The effect of ketogenic diet on the serum levels of ketone bodies and arachidonic acid and their association with oxidative stress indices in children with drug-resistant epilepsy
The Evaluation and comparison of the serum levels of ketone bodies, arachidonic acid, and oxidative stress factors in children with drug-resistant epilepsy before and after the ketogenic diet.
Design
A before and after clinical trial with an interventional group before and after.
Settings and conduct
The samples will be collected before and after the intervention in a -70°C freezer in Pediatric Health Research Center at Tabriz children Hospital. َAfter the sampling, biochemical factors will be evaluated and compared statistically.
Participants/Inclusion and exclusion criteria
Among children under the age of 18 years with drug-resistant epilepsy referring to the neurology department of Tabriz Pediatric Center, 30 patients were randomly selected after the initial diagnosis and confirmation of the disease, and after obtaining the consent will be included in the study (including criteria). Excluding criteria will include pathological underlying diseases affecting the metabolism of the drug, such as liver impairment, renal failure, blood diseases, and malignancies.
Intervention groups
Patients under the supervision of a physician will undergo a six-month course of ketogenic diet, which includes a ratio of 4 to 1 or 3 to 1 (in children of low age) from fat to carbohydrates plus proteins. Three months after the onset of the diet (second-line blood collection) and after the end of six months (third-order blood sampling), blood sampling will be done from the patients.
Main outcome variables
Serum levels of beta-hydroxybutyrate, arachidonic acid, and oxidative stress indices (MDA and 8-OHdG) will be different before and after the ketgenic diet.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131012014988N4
Registration date:2018-05-15, 1397/02/25
Registration timing:registered_while_recruiting
Last update:2018-05-15, 1397/02/25
Update count:0
Registration date
2018-05-15, 1397/02/25
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
2018-04-21, 1397/02/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ketogenic diet on the serum levels of ketone bodies and arachidonic acid and their association with oxidative stress indices in children with drug-resistant epilepsy
Public title
The Effect of Ketogenic Diet in the Treatment of Drug-Resistant Epilepsy
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Children under the age of 18 with epilepsy
Patients referring to the neurology department of Tabriz Children Hospital.
Exclusion criteria:
Having pathological underlying diseases affecting the metabolism of drugs such as liver impairment, renal failure, blood diseases, and malignancies.
Age
To 18 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
Regional Ethics Committee of Tabriz University of Medical Sciences
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.TBZMED.REC.1396.1110
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
The serum level of beta-hydroxybutyrate that is the index of the ketone bodies.
Timepoint
At the beginning of the study (before the intervention), three, and six months after the onset of the ketogenic diet.
Method of measurement
Spectrophotometry
2
Description
Serum level of arachidonic acid that is an unsaturated fatty acid.
Timepoint
At the beginning of the study (before the intervention), three, and six months after the onset of the ketogenic diet.
Method of measurement
Enzyme linked-immunosorbent assay (ELISA)
3
Description
The serum levels of malondialdehyde (MDA) that is an oxidative stress marker of the lipids.
Timepoint
At the beginning of the study (before the intervention), three, and six months after the onset of the ketogenic diet.
Method of measurement
Spectrophotometry
4
Description
The serum levels of 8-Hydroxydeoxyguanosine (8-OHdG) that is an oxidative stress marker of DNA.
Timepoint
At the beginning of the study (before the intervention), three, and six months after the onset of the ketogenic diet.
Method of measurement
Enzyme linked-immunosorbent assay (ELISA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients under the supervision of a physician will undergo a six-month course of ketogenic diet, which includes a ratio of 4 to 1 or 3 to 1 (in children of low age) from fat to carbohydrates plus proteins. That means about 90 percent of the daily calories needed in this diet will come from fat.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Mohammad Barzegar
Street address
Pediatric Health Research Center, Children Hosp.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir
Web page address
http://childrenhospital.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
http://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Office of the Vice Chancellor for Research of 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. Moahhamad Barzegar
Position
Pediatric Neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Moahhamad Barzegar
Position
Pediatric Neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sina Raeisi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
raeisis@tbzmed.ac.ir
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