The aim of this study will evaluate the radioprotective effect of vitamin E and selenium separately and synergisticaly on human blood lymphocytes.
Design : The study population consisted of 15 human volunteers will be that After taking the form of moral satisfaction from them , are divided into three groups.
A group( each person 800mg Vitamin E before blood sampling)
B group( each person 32mg Seenium before blood sampling)
C group( each person 18 mg selenium and 400 mg vitamin E before blood sampling). They each receive the drug orally.
Blood sampling done before and 1, 2 and 3 hours after receive the drug orally. After that, blood samples are irradiated with 2 Gy X-ray.
Participants in the study were healthy and non-smokers with no specific disease.
Finally chromosomal damage in human blood samples will be evaluated by micronuclei test.
General information
Acronym
no thing
IRCT registration information
IRCT registration number:IRCT2015090123843N1
Registration date:2015-10-12, 1394/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Aram Rostami
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 6655
Email address
rostamy_1969@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment of radioprotector effect of Selenium and Vitamin E synergically againt 6Mv X-ray in human blood lymphocyte by micronucli assay.
Public title
The effect of vitamin E and selenium to reduce the harmful effects of radiation
Purpose
Prevention
Inclusion/Exclusion criteria
People should be healthy and whitout any disease-specific and non-smokers
Age
From 22 years old to 30 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tehran University of Medical Sciences
Street address
Chief of Assistance of Tehran University of Medical Sciences, 6 Floor, Central Building of Tehran University of Medical Sciences, Keshavarz Avenue,
City
Tehran
Postal code
----
Approval date
2014-02-14, 1392/11/25
Ethics committee reference number
24359
Health conditions studied
1
Description of health condition studied
Factors influencing health status and contact with health services
ICD-10 code
Z00
ICD-10 code description
General examination and investigation of persons without complaint and reported diagnosis
Primary outcomes
1
Description
Reduce Chromosomal Damage in Human's Volunteer Blood Lymphocytes
Timepoint
1 , 2 and 3 Hour after sampling
Method of measurement
Micronucli Assesment
Secondary outcomes
empty
Intervention groups
1
Description
Group A: each person will receive 800mg Vitamin E before blood sampling
Category
Treatment - Other
2
Description
Group B: Participants will receive 32mg Selenium before blood sampling
Category
Treatment - Drugs
3
Description
Group C: Participants will receive 18 mg selenium and 400 mg vitamin E before blood sampling
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiation Biology and Radiology Group of Tehran University of Medical Sciences
Full name of responsible person
Aram Rostami
Street address
Paramedicl Faculty of Tehran University of Medical Sciences, NO 4, Fardanesh Alley, 16 Azar Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistance of Tehran University of Medical Sciences
Full name of responsible person
Chief of Assistance
Street address
Chief of Assistance of Tehran University of Medical Sciences, 6 Floor, Central Building of Tehran University of Medical Sciences, Keshavarz Avenue,
City
Tehran
Grant name
پایان نامه های کارشناسی ارشد
Grant code / Reference number
24359
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Aram rostami
Position
Msc
Other areas of specialty/work
Street address
Paramedicl Faculty of Tehran University of Medical Sciences, NO 4, Fardanesh Alley, 16 Azar Ave
City
Tehran
Postal code
00982188776656
Phone
+98 21 8877 6656
Fax
+98 21 8877 6656
Email
rostamy_1969@yahoo.com
Web page address
----
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aram rostami
Position
Msc
Other areas of specialty/work
Street address
Paramedicl Faculty of Tehran University of Medical Sciences, NO 4, Fardanesh Alley, 16 Azar Ave
City
Tehran
Postal code
---
Phone
+98 21 8877 6656
Fax
+98 21 8877 6656
Email
rostamy_1969@yahoo.com
Web page address
----
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aram Rostami
Position
Msc
Other areas of specialty/work
Street address
Paramedicl Faculty of Tehran University of Medical Sciences, NO 4, Fardanesh Alley, 16 Azar Ave
City
Tehran
Postal code
Phone
+98 21 8877 6656
Fax
+98 21 8877 6656
Email
rostamy_1969@yahoo.com
Web page address
----
Sharing plan
Deidentified Individual Participant Data Set (IPD)