Comparison of vitamin E and C with placebo on level of double-stranded DNA breaks lymphocytes of in patients underwent CT scan with iodine contrast media: a clinical trial
The aim of this study is the reduction of DNA Double Strand Break (DSB) in patients undergoing CT scan with Iodine Contrast Medium.This study is going to be run Randomized, double-label, and single-center, placebo-controlled. Thereafter, 60 patients that refer for abdomen/ pelvis CT scan to the Kashan’s Shahid Beheshti Hospital will be chosen. The patients will be categorized into three group including control, Vitamin C and Vitamin E groups using stratified block randomization method, based on the inclusion and exclusion criteria. After singing the written consent, patients in intervention groups receive the vitamin one hour before CT scan test. The blood sample is taken instantly after the CT scan from every individual patient. After separation and staining of the Lymphocytes, the number of breaks are counted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091029720N2
Registration date:2016-10-22, 1395/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-22, 1395/08/01
Registrant information
Name
Seyed Masoud Jafarpour
Name of organization / entity
Kashan University of Medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 31 5553 0353
Email address
jafarpour-ma@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences.
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vitamin E and C with placebo on level of double-stranded DNA breaks lymphocytes of in patients underwent CT scan with iodine contrast media: a clinical trial
Public title
The effect of vitamin E and C on reducing CT scan damages.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: referring patients to the Radiology section of Kashan’s Shahid Beheshti Hospital for abdomen/pelvis CT scan with Iodine Contrast Medium; Age Range of 18-65 years old.
Exclusion criteria: patients under radiotherapy, chemotherapy or nuclear medicine history during the last six months; diagnostic exposure three days before the test; suffering from leukemia of lymphoma; younger than 18 years or older than 65 years.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients are randomized into three groups through stratified block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Qutbe ravandi Blvd,Kashan.
City
Kashan
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.KAUMS.REC.1394.139
Health conditions studied
1
Description of health condition studied
patients undegoing CTscan
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
DNA double strand breaks
Timepoint
Before and immidiatly after CTscan
Method of measurement
fluoroscense microscope and count number of foci/cell
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Ascorbic Acid, 500 mg vitamin C, 1 hour before CT scan, single dose, Osvahpharma co.
Category
Treatment - Drugs
2
Description
control group: Placebo, Starch, 1 hour before CT scan, single dose.
Category
Placebo
3
Description
Intervention group 2: Alpha-Tocopherol, 400 IU vitamin E, 1 hour before CT scan, single dose, Zahravi laboratory
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Medical Center
Full name of responsible person
Dr Hamid Reza Talari
Street address
Qutbe ravandi Blvd,Kashan.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Qutbe ravandi Blvd, Kashan.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Kashan 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
Kashan University of Medical Scienses
Full name of responsible person
Dr Mehran Mohseni
Position
PhD in medical physics
Other areas of specialty/work
Street address
Qutbe Ravandy Blvd,Kashan.
City
Kashan
Postal code
Phone
00
Fax
Email
mehran.m1352@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Scienses
Full name of responsible person
Seyed Masoud Jafarpour
Position
MS student in medical physics
Other areas of specialty/work
Street address
Qutbe Ravandy Blvd,Kashan.
City
Kashan
Postal code
Iran
Phone
+98 31 5553 0353
Fax
Email
m.jafarpour69@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Masoud jafarpour
Position
MS in medical physics
Other areas of specialty/work
Street address
Qutbe Ravandi Blvd, Kashan.
City
Kashan
Postal code
Phone
00
Fax
Email
m.jafarpour69@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)