Aims: we studied the effect of vitamin E as an antioxidant on oxidative stress markers such as Malone dialdehyde(MDA) and protein carbonyl(PC) in idiopathic epilepsy children with vitamin D deficiency.
Design: Idiopathic epilepsy children were divided into two groups. One group treated with 50000 Iu vitamin D for 8 weeks and the other was treated with 100 unit vitamin E daily plus 50000 Iu vitamin D for 8 weeks. MDA and PC were measured by Spectrophotometer method. Data was analyzed by SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060113051N3
Registration date:2015-08-03, 1394/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-03, 1394/05/12
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
Yazd University of Medical Sciences
Expected recruitment start date
2013-01-15, 1391/10/26
Expected recruitment end date
2014-11-14, 1393/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin E on Oxidative stress markers lipids,protein, in chideren suffering of idiopathic Epilepsy
Public title
Effect of Vitamin E on Epilepsiy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 2-14 years old; idiopathic epilepsy and no history of Vitamin D or E administration in last two months.
Exclusion criteria: allergic diseases; mental retardation.
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
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
1
Registry name
student thesis
Secondary trial Id
1393
Registration date
1992-12-12, 1371/09/21
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences Ethic commity
Street address
Yazd University of Medical Sciences, Bahonar Sq.
City
Yazd
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1392-245
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy
Primary outcomes
1
Description
Vitami D
Timepoint
At the beginning of the study
Method of measurement
ELISA
Secondary outcomes
1
Description
Vitamin E
Timepoint
At the beginnig and end of the study
Method of measurement
ELSIA
Intervention groups
1
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Univesity od medical Science
Full name of responsible person
Dr Mehran Karimi
Street address
yazd. Bouvar Shhid Ghandi
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mehrparvar
Street address
Yazd University of Medical Sciences, Bahonat Sq.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Dept of Biochemistry, Yazd University of Medical Science
Full name of responsible person
Dr Javad Mohiti
Position
PhD in Biochemistry
Other areas of specialty/work
Street address
Yazd University of Medical Science, Bahonar Sq.
City
Yazd
Postal code
Phone
+98 35 3823 2773
Fax
+98 35 3725 9092
Email
mohiti_99@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dept of Biochemistry, Yazd University of Medical Science
Full name of responsible person
Dr Javad Mohiti
Position
PhD in Biochemistry
Other areas of specialty/work
Street address
Yazd University of Medical Science, Bahonar Sq.
City
Yazd
Postal code
Phone
+98 35 3823 2773
Fax
+98 35 3725 9092
Email
mohiti_99@yahoo.com
Web page address
www.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dept of Biochemistry, Yazd University of Medical Science
Full name of responsible person
Dr. Javad Mohiti
Position
PhD in biochemistry
Other areas of specialty/work
Street address
Yazd University of Medical Science, Bahonar Sq.
City
Yazd
Postal code
Phone
+98 35 3823 2773
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)