Effect of vitamin c on salivary total antioxidant capacity
Design
The present study was designed as a randomized clinical trial.60 smokers who have been referred to oral medicine department of dental school of Rafsanjan University of medical sciences were included in the study. Then, patients were randomly divided into three groups including: control and intervention groups.
Settings and conduct
For the baseline activity, at least 1 mL of each patient’s unstimulated saliva collect in the beginning of study. Collected saliva transferre to laboratory and place in specific microtubules immediately. To separate the squamous cells and derbies, samples centrifuge for 15 min.Then, centrifuge samples preserve at -20°C to be assessed later
Participants/Inclusion and exclusion criteria
Healthy male Smokers with the history of 5 or more pack/year of smoking enter to the study.They have no systemic disease, no history of chemotherapy or radiotherapy, do not take any medications continuously during the past 3 months, do not take alcohol and supplements, and do not have nephrolithiasis. They also haveno oral pathology based on clinical examination.
Intervention groups
Group A, receive 1000 mg of vitamin C Effervescent tablets daily and group B receive 500 mg of vitamin C Effervescent tablets per day for three weeks, and the control group does not receive any supplements.
Main outcome variables
Salivary total antioxidant capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171203037717N1
Registration date:2018-01-09, 1396/10/19
Registration timing:prospective
Last update:2018-01-09, 1396/10/19
Update count:0
Registration date
2018-01-09, 1396/10/19
Registrant information
Name
nazanin kamyab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0031
Email address
nazanin.kamyab@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-16, 1396/10/26
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin C on salivary total antioxidant capacity in healthy male smokers
Public title
Effect of vitamin c in smokers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
male
smoker
health
Exclusion criteria:
systemic disease
history of chemotherapy or radiotherapy
take any medications continuously during the past 3 months
have nephrolithiasis
take alcohol and supplements
oral pathology based on clinical examination
Age
From 25 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
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 Rafsanjan University of Medical Sciences
Street address
Building No. 3,Central Department of Rafsanjan University of Medical Science,Emam Ali Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.RUMS.REC.1396.58
Health conditions studied
1
Description of health condition studied
total anti oxidant capacity
ICD-10 code
Z00
ICD-10 code description
Encounter for general examination without complaint, suspected or reported diagnosis
Primary outcomes
1
Description
total antioxidant capacity in healthy smokers
Timepoint
at the beginning of study and 20 days after taking vitamin c
Method of measurement
total anti oxidant capacity assay kits
Secondary outcomes
1
Description
salivary total antioxidant capacity
Timepoint
At the beginning of study and 20 days after receive vitamin c
Method of measurement
Total antioxidant capacity assay kits
Intervention groups
1
Description
Intervention group: 1000 mg boiling tablets of vitamin c each day for 20 days
Category
Treatment - Drugs
2
Description
Intervention group: 500mg boiling tablets of vitamin c each day for 20 days
Category
Treatment - Drugs
3
Description
Control group: receive no placebo
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Rafsanjan university of medical sciences
Full name of responsible person
Nazanin Kamyab
Street address
Dental school, West Sahid Mofateh Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Email
nazaninkamyab@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Atekeh Movaghari Pour
Street address
Dental School, West Shahid Mofath Blvd
City
Rafsangan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Fax
+98 34 3428 0008
Email
dentistry@rums.ac.ir
Web page address
http://dentistry.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Nazanin Kamyab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School,West Shahid Mofateh Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
nazanin.kamyab@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Nazanin Kamyab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, West Shahid Mofateh Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
nazanin.kamyab@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Nazanin Kamyab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, West Shahid Mofateh Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
nazanin.kamyab@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
access to all data
When the data will become available and for how long
Getting started from 2018
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
No other conditions required
From where data/document is obtainable
nazanin.kamyab@rums..ac.ir
What processes are involved for a request to access data/document
Having an organizational email and verification of the title and code of ethics recorded