We studied the effect of vitamin E as an antioxidant on oxidative stress markers such as Malone dialdehyde (MDA) and protein carbonyl (PC) in 30 idiopathic epilepsy children aged 2-14 years with vitamin D deficiency. The patients were divided to two groups. One group treated with 50000 unit vitamin D for 8 weeks and the other was treated with 100 unit vitamin E daily plus 50000 unit vitamin D for 8 weeks. Inclusion criteria: having idiopathic epilepsy According to the International Association; Having vitamin D deficiency; not taking vitamin E and D In the past two months
Exclusion criteria: Having a history of allergy to drugs; Any underlying systemic disease that prevent Medications; strickening Symptomatic epilepsy; strickening Mental retardation
General information
Acronym
Epilepsy therapy
IRCT registration information
IRCT registration number:IRCT2013041713051N1
Registration date:2015-09-07, 1394/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-07, 1394/06/16
Registrant information
Name
Javad Mohiti Ardekani
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1820 3410
Email address
mohiti@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-06-23, 1392/04/02
Expected recruitment end date
2014-12-23, 1393/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the vitamin E effect on oxidative stress markers of proteins and lipids in children with idiopathic epilepsy
Public title
The effedt of vitmin E on Epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
The study population included all children 14-2 years old that have been referred to pediatric neurology clinic of Yazd University of Medical Sciences. After taking a history and doing a physical examination and a specialty based on clinical judgment nervous children with idiopathic epilepsy were selected.
Inclusion criteria: having idiopathic epilepsy According to the International Association; Having vitamin D deficiency; not taking vitamin E and D In the past two months
Exclusion criteria: Having a history of allergy to drugs; Any underlying systemic disease that prevent Medications; strickening Symptomatic epilepsy; strickening Mental retardation
Age
From 2 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Science, Shahid Sadughi University of Medical Sciences
Street address
Shahid Sadughi University of Medical sciences, Bahonar St. Yazd
City
yazd
Postal code
Approval date
2015-04-22, 1394/02/02
Ethics committee reference number
IR.SSU.MEDICINE.REC.1393.102
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
Malone dialdehyde
Timepoint
Before Intervention and two months after that
Method of measurement
Spectrophotometry
2
Description
carbonyl group
Timepoint
Before Intervention and two months after that
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
The number of seizures
Timepoint
Before intervention and two months after that
Method of measurement
Questionnaire
Intervention groups
1
Description
The first group(control) was treated with oral capsules of 50000 units weekly, for 8 weeks
Category
Treatment - Drugs
2
Description
the second group(intervention) was treated with oral capsules of 50000 units weekly, for 8 weeks and pill of 100 IU vitamin E for a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Shahid Sadughi Hospital
Full name of responsible person
Sona Rezaei
Street address
Shahid Sadughi Hospital, Shahid Ghandi Street
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amirhoushang Mehrparvar
Street address
Shahid Sadughi University of Medical sciences, Bahonar St. Yazd
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences
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
Shahid Saddughi University of Medical Sciences
Full name of responsible person
Dr. Javad Mohiti
Position
Ph.D, Biochemistry
Other areas of specialty/work
Street address
Faculty of Medicine, Pardis University, Shahid bahonar Street,
City
Yazd
Postal code
Phone
+98 35 3820 3410
Fax
+98 35 3725 9092
Email
mohiti@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Science, Shahid Sadughi University of Medical siences, yazd
Full name of responsible person
Dr. Javad Mohiti
Position
Ph.D
Other areas of specialty/work
Street address
Shahid Sadughi University of Medical sciences, Bahonar St. Yazd
City
Yazd
Postal code
Phone
+98 35 3820 3410
Fax
+98 35 3725 9092
Email
mohiti@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadugi University of Medical Sciences
Full name of responsible person
Sona Rezaei
Position
MS.c
Other areas of specialty/work
Street address
Shahid Sadughi University of Medical sciences, Bahonar St. Yazd
City
Yazd
Postal code
45657225
Phone
+98 35 3920 3410
Fax
+98 35 3725 9092
Email
sonarezaei@yahoo.com
Web page address
www.ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)