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Study the expression of CCR2, PPAR-G and NF-κB in peripheral blood leukocytes, oxidative stress and seizure frequency in drug-resistant epileptic patients, after combination therapy with High DHA/EPA PUFA and Ascorbic acid

Protocol summary

Study aim
Study the effect of combined treatment with High DHA/EPA omega3 and ascorbic acid on the expression levels of PPAR-G, CCR2 and NF-κB genes in peripheral blood leukocytes, oxidative stress and seizure frequency in drug-resistant epileptic patients.
Design
This study will be a cross over clinical trial, with a control group, randomized, phase 2-3 and on 30 patients
Settings and conduct
It will be conducted in Ardabil University of Medical Sciences on patients with DRE referred to the neurology clinic. Before the intervention, the expression levels of PPAR-G, CCR2 and NF-kB genes & the oxidative stress marker MDA, will be measured in the patients' blood. Also, this measurement is done again at the end of the first quarter and at the end of the second quarter .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Epileptic patients(with at least two antiepileptic drugs) and at least one seizure in the last 6 months, 18+ years old. Exclusion criteria: pregnancy, history of: chronic kidney disease, heart attack or vascular interventions, kidney stones, use of anticoagulants, sensitivity to ascorbic acid or omega-3, familial dyslipidemia or acquired dyslipidemia, lack of patient willingness to continue receiving combination therapy
Intervention groups
This study which is a randomized clinical trial, 30 patients with drug-resistant epilepsy(DRE) will be randomly divided into 2 groups of 15 people, A and B. First, for 4 months, group A which will receive their usual antiepileptic treatment also , will receive daily combination treatment ( High DHA/EPA PUFA and ascorbic acid). But group B will only receive their usual antiepileptic treatment. After the 4-month intervention period, the groups will be changed. (It is a "Cross over" study)
Main outcome variables
CCR2, PPAR-G, NF-kB gene expression, seizure frequency, MDA as oxidative stress indicator

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240220061057N1
Registration date: 2024-04-29, 1403/02/10
Registration timing: prospective

Last update: 2024-04-29, 1403/02/10
Update count: 0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Rezvan Parkalian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2297 1426
Email address
parkalianrezvan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-07-06, 1403/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the expression of CCR2, PPAR-G and NF-κB in peripheral blood leukocytes, oxidative stress and seizure frequency in drug-resistant epileptic patients, after combination therapy with High DHA/EPA PUFA and Ascorbic acid
Public title
The effect of high DHA/EPA PUFA and ascorbic acid in the treatment of refractory epileptic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Epileptic patients who take at least two antiepileptic drugs but have had at least one seizure in the last 6 months. Patients are at least 18 years old Willingness to participate in the study
Exclusion criteria:
pregnancy chronic kidney disease history of MI or vascular interventions history of renal stone use of anticoagulants history of allergy to ascorbic acid or DHA/EPA PUFA history of familial or acquired dyslipidemia The patient unwillingness to continue the combined treatment
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
Blood sample to measure the mentioned variables in the first time period (first 4-month) of the study and then again sample in the second time period of the study (second 4-month). (The study is of cross over type).
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent from 30 treatment-resistant epileptic patients, they will be divided into 2 groups of 15 people in a simple random manner. In a bag of 30 cards, 15 numbers will be named A and 15 will be named B. Patients will randomly pick a card from the bag without seeing it and will be placed in one of the A or B groups. Of course, considering that the study is a "Cross over" study, in the first period of the study, group A will receive supplements and group B will not. Then, after the supplement wash out period, the type of supplement administration would change in the groups. In other words, in the second time period, it is group A that does not receive treatment with supplements, but group B does. Randomization method: simple, randomization unit: individual, randomization tool: sealed envelope
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil, Ayatollah Moghdisi Ardabili St., Shahid Maadi St., Alavi Medical Training Center
City
اردبیل
Province
Ardabil
Postal code
5613974156
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.ARUMS.REC.1402.298

Health conditions studied

1

Description of health condition studied
seizure
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures

Primary outcomes

1

Description
CCR2 gene expression level
Timepoint
before the start of the intervention and after the first period (end of the first four months) and again after the second period (end of the second quarter). (The study is of cross-over type and in the second quarter, the place of intervention of the groups is moved).
Method of measurement
Real-time q PCR method

2

Description
PPAR-G gene expression level
Timepoint
before the start of the intervention and after the first period (end of the first four months) and again after the second period (end of the second quarter). (The study is of cross-over type and in the second quarter, the place of intervention of the groups is moved).
Method of measurement
Real-time q PCR

3

Description
NF-kB gene expression level
Timepoint
before the start of the intervention and after the first period (end of the first four months) and again after the second period (end of the second quarter). (The study is of cross-over type and in the second quarter, the place of intervention of the groups is moved).
Method of measurement
Real-time q PCR

4

Description
Oxidative stress marker: MDA
Timepoint
before the start of the intervention and after the first period (end of the first four months) and again after the second period (end of the second quarter). (The study is of cross-over type and in the second quarter, the place of intervention of the groups is moved).
Method of measurement
by laboratory measurement (according to the protocol of the purchased kit)

5

Description
Seizure frequency
Timepoint
before the start of the intervention and after the first period (end of the first four months) and again after the second period (end of the second quarter). (The study is of cross-over type and in the second quarter, the place of intervention of the groups is moved).
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group : patients will be placed in two groups A and B after random allocation. 15 patients in intervention group A will receive routine anticonvulsant treatments, and in addition, They will receive one ascorbic acid tablet with a dosage of 500 mg every morning and one High DHA/EPA PUFA with a dosage of 500 mg of DHA and 150 mg of EPA in each capsule every evening for four months and after that they will only receive their routine anticonvulsant treatments for four months. The expression level of PPAR-G, CCR2 and NF-κB genes in peripheral blood leukocytes, oxidative stress and frequency of seizure attacks in patients of this group will be measured before the intervention and four months after the intervention and at the end of the intervention.
Category
Treatment - Drugs

2

Description
Control group: patients will be placed in two groups A and B after random allocation. 15 patients in the control group will only receive routine anticonvulsant treatments in the first four months, and after that, for four months, in addition to their routine anticonvulsant treatments, one ascorbic acid tablet with a dosage of 500 mg every morning and one High DHA EPA/PUFA tablet every evening with a dosage of 500 mg of DHA and 150 mg of EPA per capsule. The expression level of PPAR-G, CCR2 and NF-κB genes in peripheral blood leukocytes, oxidative stress and frequency of seizure attacks in patients of this group will be measured before the intervention and four months after the intervention and at the end of the intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil, Ayatollah Moghaddis Ardabili St., Shahid Maadi St., Alavi Medical Education Center
Full name of responsible person
Qasim Fattahzadeh
Street address
Ayatollah Moghaddis Ardabili St., Shahid Maadi St., Ardabil Alavi Hospital, Neurology Clinic
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
alavi@arums.ac.ir
Web page address
https://alavi.arums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
.
Street address
End of University Street, Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3353 4790
Fax
+98 45 3353 4773
Email
portal@arums.ac.ir
Web page address
https://arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Qasim Fattahzadeh
Street address
End of University Street, Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3353 4790
Email
portal@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Supervisor Mr. Dr. Fatah Zadeh
Proportion provided by this source
50
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Rezavan Parkalian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ayatollah Moghaddis Ardabili St., Shahid Maadi St., Alavi Educational and Medical Center
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
Email
parkalianrezvan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Qasim Fattahzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Ayatollah Moghaddis Ardabili St., Shahid Maadi St., Alavi Educational and Medical Center
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
gh.fattahzadeh@arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Rezvan Parkalian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ayatollah Moghaddis Ardabili St., Shahid Maadi St., Alavi Educational and Medical Center
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
parkalianrezvan@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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