Study the effect of metabolic treatment based on a diet containing CAPRIDIN on adenosine regulatory pathways in brain tissue of patients with drug-resistant epilepsy
Determining the effect of metabolic treatment based on CAPRIDIN consumption on adenosine regulatory pathways in the brain tissue of patients with drug-resistant temporal lobe epilepsy
Design
A clinical trial with a control group, with parallel groups, non blinded, randomized, phase 1-2 on 10 patients.
Settings and conduct
A number of 10 patients who refer to the Neurological Center of Imam Khomeini Hospital due to refractory temporal lobe epilepsy. After the face-to-face training session, the intervention group consumes a capridin product produced by HealthWeX Company (Canada) for 2 months, fasting consumption daily, at an average of 30 cc. In order to reduce dietary carbohydrate sources, general instructions are given to patients. Non-blind study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 15 to 65 with a history of chronic epilepsy whom neurologists diagnose as candidates for surgery.
Exclusion criteria:
1) Any previous consumption of any types of ketogenic diet
2) Metabolic syndrome patients
Intervention groups
Patients assigned to the intervention group, in addition to the standard treatment, during the two months before surgery, receive an average of 30 cc of CAPRIDIN daily with food. Patients in the control group received only standard epilepsy treatment during this period.
Main outcome variables
Expression level of ecto-5-nucleotidase (CD73) in the patients brain tissue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170315033086N11
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Saeed Karima
Name of organization / entity
Shahid Beheshti University of Medical Sciences (SBMU)
Country
Iran (Islamic Republic of)
Phone
+98 21 9666 1028
Email address
karima@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of metabolic treatment based on a diet containing CAPRIDIN on adenosine regulatory pathways in brain tissue of patients with drug-resistant epilepsy
Public title
Study the effect of CAPRIDIN in the metabolic treatment of drug-resistant epilepsy
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with drug-resistant temporal lobe epilepsy
Taking up to 3 or more standard anticonvulsants
Having at least 3 seizures per month.
Exclusion criteria:
Failure to adhere to dietary guidelines.
Metabolic syndrome
Pregnancy
Age
From 15 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
- "Random Allocation V.2" software is used for randomization.
This software can be downloaded from the following link:
https://random-allocation-software.software.informer.com
In this study, one block is used for the randomization.
- Patients will be allocated in two intervention and control groups in equal numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medicine, Shahid Beheshti University of Medical Sciences and Health S
Street address
Shahid Chamran highway - Evin - next to Taleghani hospital - medical school - ground floor
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.SBMU.MSP.REC.1401.613
Health conditions studied
1
Description of health condition studied
Drug-resistant temporal lobe epilepsy
ICD-10 code
G40.2
ICD-10 code description
Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Primary outcomes
1
Description
Expression level of ecto-5-nucleotidase (CD73) in the patients brain tissue
Timepoint
Two months after taking CAPRIDIN and then brain tissue sampling after surgery.
Method of measurement
Using Real-Time PCR and Western blot techniques
2
Description
Expression level of adenosine kinase in the patients brain tissue
Timepoint
Two months after taking CAPRIDIN and then brain tissue sampling after surgery.
Method of measurement
Using Real-Time PCR and Western blot techniques
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients who take 30 cc of CAPRIDIN daily with food, in addition to the standard treatment of epilepsy, for an average of two months. Capridin is a product of HealthWeX (Canada) that contains medium chain fatty acids. These compounds are used in ketogenic diets and induce ketogenesis. Treatments based on ketogenesis in the control of epilepsy are among the approved treatments for this disease.
Category
N/A
2
Description
Control group: patients are receiving only standard epilepsy treatment. Antiepileptic drugs are often used as the first line of treatment and as standard treatment. The most important antiepileptic drugs include phenobarbital, carbamazepine, phenytoin, valproic acid, lamotrigine, and levetiracetam. Depending on the specialist doctor's diagnosis and the individual's clinical conditions, any of these drugs may be prescribed for patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Abbas Tafakhori
Street address
Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1420
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Karima
Street address
Department of Clinical Biochemistry, Shahid Behehshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 9666 1028
Email
karima@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Behbalin Inc.
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Karima
Position
Assistant Professor of Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Clinical Biochemistry, Shahid Behehshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2570
Email
karima@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Tafakhori
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1420
Email
Imamhospital@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Hossein Khatami
Position
Clinical biochemist
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Clinical Biochemistry, Shahid Behehshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2570
Email
shossein.khatami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Collected deidentified IPD, IPD collected for the primary outcome measure only.
When the data will become available and for how long
Deidentified data will be available starting from March 2026
To whom data/document is available
Who are working in academic institutions or working in nutritional companies. .
Under which criteria data/document could be used
No specific condition.
From where data/document is obtainable
Saeed Karima (Floor 8, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran. Iran)
Email: karima@sbmu.ac.ir
What processes are involved for a request to access data/document
The process: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided within one month.