The aim of this study is to determine the effects of vitamin D supplementation on mental health parameters, oxidative stress and inflammatory biomarkers in cigarette smokers.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: 60 eligible cigarette smokers and referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cigarette smokers and aged 17 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention: Patients will be assigned to receive either vitamin D (n=30) or placebo (n=30).
Main outcome variables
Mental health parameters (primary outcome), oxidative stress and inflammatory biomarkers (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170420033551N7
Registration date:2019-07-15, 1398/04/24
Registration timing:retrospective
Last update:2019-07-15, 1398/04/24
Update count:0
Registration date
2019-07-15, 1398/04/24
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of vitamin D supplementation on mental health parameters, oxidative stress and inflammatory biomarkers in cigarette smokers
Public title
Effect of vitamin D supplementation in cigarette smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Smoking dependence
Age of 17 to 60 years old
Exclusion criteria:
Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician
Current opioid, alcohol or sedative physical dependence or cocaine dependence
Metabolic diseases such as diabetes and neurological diseases such as epilepsy
Unwillingness to cooperate
Current severe depression and mania psychosis
Age
From 17 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<40 and ≥40 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2019-06-08, 1398/03/18
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.026
Health conditions studied
1
Description of health condition studied
Nicotine dependence in cigarette smokers
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes
Primary outcomes
1
Description
Depression beck score
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Questionnaire
2
Description
Anxiety beck score
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
HDL
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Insulin
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Elisa kit
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Hs-CRP
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Elisa kit
9
Description
Total glutathione
Timepoint
At the beginning of the study and 24 weeks after intervention
Method of measurement
Spectrophotometry
10
Description
Malondialdehyde
Timepoint
At the beginning of the study and 24 weeks after intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once every 2 weeks, for 24 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), once every 2 weeks, for 24 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Hamid Reza Banafshe
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 4455 2200
Email
banafshe57@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
gaderiam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Azam mesdaghinia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
mesdaghiniaazam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
gaderiam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available