Effect of vitamin C on salivary total antioxidant capacity
in healthy non-smokers
Design
In this study, 60 healthy non smokers who are qualified and referred to the Dental School of Rafsanjan are selected. patients are selected randomly and divided into three groups of A and B and C .
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 transfere 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
It examined on non smokers client in 25-50 years old with no systemic disease or any kind of treatment history and radiotherapy, who had gone to the Rafsanjan Dentistry College.
Intervention groups
group A, receive 1000 mg of vitamin C boiling tablets daily and group B receive 500 mg of boiling tablets of vitamin C 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:IRCT20171203037717N2
Registration date:2018-02-01, 1396/11/12
Registration timing:retrospective
Last update:2018-02-01, 1396/11/12
Update count:0
Registration date
2018-02-01, 1396/11/12
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
2017-12-17, 1396/09/26
Expected recruitment end date
2017-12-21, 1396/09/30
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 non-smokers
Public title
Effect of vitamin C in non-smokers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
non-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
Both
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
Healthy 25-50 years old non-smoker clients of oral disease section of Rafsanjan Dentistry College for oral examination, by randomly permuted blocks of 3 to assign patients to groups of 1000 mg receiver of vitamin C , 500 mg receiver of vitamin C and control group .
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
Rafsanjan, Imam Ali Blvd, Central Office of Rafsanjan University of Medical Sciences, Building No. 3,
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
empty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total antioxidant capacity in healthy non-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
empty
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
Dentistry university of Rafsanjan
Full name of responsible person
nazanin kamyab
Street address
Western shahid mofateh Blvd, next to Ali ibn abitaleb hospital
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Email
nazanin.kamyab@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
nazanin kamyab
Street address
Western shahid mofateh Blvd, next to ali ibn abitaleb hospital
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
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
Other
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
Western shahid mofateh Blvd. next to Ali ibn abitaleb hospital
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
Western shahid mofateh Blvd. next to Ali ibn abitaleb hospital
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
Western shahid mofateh Blvd, next to Ali ibn abitaleb hospital
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