Evaluating the effect of vitamin C on apoptosis compared to control group on apoptosis in peripheral blood lymphocytes in patients treated with ablation in cardiac electrophysiology studies
The aim of this study is to evaluate the radioprotective effect of vitamin C on apoptosis in peripheral blood lymphocytes of patients undergoing ablation in cardiac electrophysiology studies. This is a single blind study.
For this reason, analyzer of information is unaware about the subject.
Blocks of permutation (three blocks) used for the randomization.
Inclusion criteria: Non-smoking; Lack of infectious disease; Do not use of antibiotics; Unexposed to ionizing radiation, 24 hours prior to sampling
Exclusion criteria: Use of multivitamins; Use of alcohol; Acute or chronic disease
A total number of 30 male and female patients aged 20 to 60 years will be selected in the same condition. Patients will be randomly divided into three groups. The first group of patients without vitamin C administration, in the second group, 3 hours before the test, 2 grams of vitamin c orally administered to patients as a tablet and the third group 3 hours before the test, one gram of vitamin c orally administered to patients as a tablet.
Before intervention and after intervention within 24 hours after the test, 3 cc blood samples taken from the patients.
Lymphocyte apoptosis will be evaluated by flow cytometry method. The ELISA method will be used to evaluate Bax and Bcl-2 proteins level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072529068N1
Registration date:2016-09-19, 1395/06/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-19, 1395/06/29
Registrant information
Name
Hamideh Nematollahi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5415
Email address
stud2420124510@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitamin C on apoptosis compared to control group on apoptosis in peripheral blood lymphocytes in patients treated with ablation in cardiac electrophysiology studies
Public title
The effect of vitamin C on lymphocyte apoptosis induced by radiation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Non-smoking; Lack of infectious disease; Do not use of antibiotics; Unexposed to ionizing radiation, 24 hours prior to sampling
Exclusion criteria: Use of multivitamins; Use of alcohol; Acute or chronic disease
Age
From 20 years old to 60 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)
Single 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 Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.SUMS.REC.1395.44
Health conditions studied
1
Description of health condition studied
Patients treated with ablation in cardiac electrophysiology studies
ICD-10 code
IX
ICD-10 code description
Atrial fibrillation and flutter, Paroxysmal tachycardia
Primary outcomes
1
Description
apoptosis
Timepoint
Before the intervention and after intervention within 24 hours after the test
Method of measurement
Counting the number of apoptotic peripheral blood lymphocytes by flow cytometry
Secondary outcomes
1
Description
Bax protein
Timepoint
Before intervention and after intervention within 24 hours after the test
Method of measurement
Counting the number of Bax protein by ELISA method
2
Description
Bcl-2 protein
Timepoint
Before intervention and after intervention within 24 hours after the test
Method of measurement
Counting the number of Bcl-2 protein by ELISA method
Intervention groups
1
Description
Vitamin C (ascorbic acid), 1 gram oral tablet, only once in 3 hours prior to the test
Category
Prevention
2
Description
Vitamin C (ascorbic acid), 2 gram oral tablet, only once in 3 hours prior to the test
Category
Prevention
3
Description
The control group without action
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of Shahid Faghihi
Full name of responsible person
Vahid Jorat (Cardiologist and associate professor)