Determine the amount of seizure reduction after the start of the ketogenic diet
Design
In order to determine the sample size, 35 children with refractory epilepsy referring to Neurology Clinic of Tabriz University of Medical Sciences were selected by simple sampling and Access will be selected and will be included in the study.
Settings and conduct
Selected patients are admitted to Tabriz Children's Hospital and begin a ketogenic diet and will be discharged from the hospital after taking the diet and continue the regimen outside the hospital and will be monitored regularly.
Participants/Inclusion and exclusion criteria
inclusion criteria : -age : 2 - 15 years -lack of seizure control using 2 first line anti epileptic drugs -on average 1 attack per month -there is no chronic disease such as liver disease or diabetes -there is no progressive neurologic disorder -parental training -informed consent
exclusion criteria: -liver disease -progressive neurologic disorders - inborn error of metabolism with ammonia level is more than normal -without informed consent
Intervention groups
Patients under the supervision of a physician will undergo a one-year treatment with a ketogenic diet, which includes a ratio of 4 to 1 or 3 to 1 (in children of low age) from fat to carbohydrates plus protein. These patients will be monitored monthly
Main outcome variables
Age, sex, type of treatment; number of seizure attacks; appropriate response to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131012014988N5
Registration date:2018-05-23, 1397/03/02
Registration timing:registered_while_recruiting
Last update:2018-05-23, 1397/03/02
Update count:0
Registration date
2018-05-23, 1397/03/02
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
2017-04-03, 1396/01/14
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and complication of ketogenic diet and modified therapy in pediatric's refractory epilepsy ketogenic diet on childhood refractory epilepsy
Public title
Efficacy of ketogenic diet in pediatric's refractory epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age : 2 - 15 years
lack of seizure control using 2 first line anti epileptic drugs
on average 1 attack per month
there is no chronic disease such as liver disease or diabetes
there is no progressive neurologic disorder
parental training
informed consent
Exclusion criteria:
liver disease
progressive neurologic disorders
inborn error of metabolism with ammonia level is more than normal
without informed consent
Age
From 2 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
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
Research and Technology Dept, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golghast St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-03-05, 1396/12/14
Ethics committee reference number
IR.TBZMED.REC.1396.1108
Health conditions studied
1
Description of health condition studied
types of refractory epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
The response rate to ketogenic diet based on the reduction of seizures
Timepoint
Based on regular monthly follow-up after the start of the ketogenic diet
Method of measurement
questionnaire
2
Description
erine keton body
Timepoint
daily
Method of measurement
urine test tape
Secondary outcomes
1
Description
Quality of life score
Timepoint
Monthly
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Patients undergoing hospitalization and kidney ultrasonography and EEG , initially, are treated with only fluid Equivalent two-thirds of the fluid required in the 24-hour period until the urine ketone is >= 2+. After that, the diet begins with lipid to a total protein and carbohydrate level of 4 to 1, and patient is discharged from the hospital. After 1 week and then monthly follow up and the rate of reduction in the number of seizures is evaluated and recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic, Children Hospital, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Mohammad Barzegar
Street address
Children Hospital, Sheshghelan Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 41 3526 2265
Email
phrc_mb@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?
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
Pediatric Neurologist, Professor, Faculty Member
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Pediatric Health Research Center, Children Hospital, Sheshghelan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Barzegar
Position
Pediatric Neurologist, Professor, Faculty Member
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Pediatric Health Research Center, Children Hospital, Sheshghelan 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
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Dr Bita Poorshiri
Position
Pediatric Neurology Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Pediatric Health Research Center, Children Hospital, Sheshghelan Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
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