Evaluation of effect of vitamin E on the seizure frequency and EEG findings and biochemical parameters of interactive epileptic patients treating with carbamazpin,sodium valproate and levetiracetam
Epilepsy is one of the common neurological disorders characterized. Vitamin E is a natural antioxidant without any significant complication which is easily used. This study aimed to evaluate the effect of this vitamin on decreased frequency of seizure and biochemical parameter and EEG finding and increasing the effects of anti epileptic drugs.
This double-blind(Blinding was performed for patients as well as researchers), random placebo-controlled clinical trial have been done on 66 patients with epilepsy treated with anti epileptic drugs referred to Kashani hospital and private clinics in Isfahan. random sampling 33 patients were allocated to intervention and control groups. The intervention group was given daily supplements of 400 IU vitamin E and the control group gave similar pills of vitamin E as placebo. Seizure frequency monthly and EEG and blood biochemical markers were measured at beginning and end of sixth months.
Inclusion criteria:Age 20-50 years
;Agreed to participate in study ; Had intractable seizure ; Family will able to count the patient seizure ; Over the past two months, the patient is taking at least one of the studied drugs
;Did not use Vit E in 6 month ago ; Lack of liver and kidney failure.
Exclusion criteria:
No satisfaction to participant in study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121925595N1
Registration date:2016-02-06, 1394/11/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Fataneh Gholami Motlagh
Name of organization / entity
Isfahan Medical univercity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 3786
Email address
leiladehghani@azh.med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Expected recruitment start date
2016-01-05, 1394/10/15
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of vitamin E on the seizure frequency and EEG findings and biochemical parameters of interactive epileptic patients treating with carbamazpin,sodium valproate and levetiracetam
Public title
Effect of Vitamin E on Seizure
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
age 20-50; satisfaction to participant in study; intractable seizure1)two seizure in month2)use two anti epileptic drug in 6 month ago at least; family can count frequency of seizure; use one of the carbamazpine or Na valproat or levetiracetam or combination in 2 month ago;did not use vit E in 6 month ago ;don't have renal or liver failure
exclusion criteria:
no satisfaction to participant in study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Univercity of Medical Science
Street address
Azadi square, Hezar jarib avn, Isfahan.
City
Isfahan
Postal code
81746-73461
Approval date
2015-02-18, 1393/11/29
Ethics committee reference number
394186
Health conditions studied
1
Description of health condition studied
Seizure
ICD-10 code
G40
ICD-10 code description
Seizure
Primary outcomes
1
Description
Frequency of seizure
Timepoint
Once a month
Method of measurement
Ask of family patient
2
Description
Evaluation of biochemical blood
Timepoint
Beginning and end of study(6 month away)
Method of measurement
Check the total anti oxidant capacity and oxidative of sample blood(microgram/mililiter)
3
Description
EEG finding
Timepoint
Beginning and end of study(6 month away)
Method of measurement
Comparison the EEG and evaluation change of epileptiform discharge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vit E 400 ml daily for six month
Category
Treatment - Drugs
2
Description
Control group: 400 milligram placebo daily for six month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal Office
Full name of responsible person
Dr. Jafar Mehvari
Street address
Amadegah Ave.
City
Isfahan
2
Recruitment center
Name of recruitment center
kashani Hospital
Full name of responsible person
Dr. Mohammad Zare
Street address
Kashani Ave.
City
Isfahan
3
Recruitment center
Name of recruitment center
Personal Office
Full name of responsible person
Dr. Mohammad Zare
Street address
Amadegah Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahanl Univercity Of Medical Science
Full name of responsible person
Vice chancellor for research,Isfahan University of Medical Sciences
Street address
Hezar Jarib Avu.,Azadi Sq.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahanl Univercity Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan Univercity of Medical Science
Full name of responsible person
Fataneh Gholami Motlagh
Position
Resident Of Neurology
Other areas of specialty/work
Street address
Isfahan.alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 3629 3786
Fax
Email
f_g_motlagh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Univercity Of Medical Science
Full name of responsible person
Dr. Mohammad Zare
Position
Professor
Other areas of specialty/work
Street address
Kashani Hospital ,Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
zare@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Univercity Of Medical Science
Full name of responsible person
Fataneh Gholami Motlagh
Position
Resident Of Neurology
Other areas of specialty/work
Street address
Isfahan.Alzahra Hospital
City
Isfahan
Postal code
Phone
00
Fax
Email
f_g_motlagh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)