The effect of vitamin D supplementation and aerobic exercise on serum concentrations of inflammatory factors and pulmonary function in male smokers
Design
The study was a phase 2, community-based and pragmatic, randomized, no blinding, controlled clinical trial on 40 subjects, and a sealed envelope was used for randomization.
Settings and conduct
The subjects of the vitamin D supplement + aerobic exercise group and the aerobic exercise group ran for 4 weeks (3 days a week) with an intensity of more than 50% of the maximum heart rate in Tabriz Stadium. In addition, subjects in the vitamin D supplement group + aerobic exercise and the vitamin D supplement group received vitamin D 1000 units per week for four weeks. Also, the control group did not have any activity or supplementation during 4 weeks of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having at least one year of smoking history and being healthy. Exclusion criteria: having clinical diseases
Intervention groups
Intervention group: 10 male smokers who did aerobic exercise for 4 weeks (running at more than 50% of maximum heart rate, 3 days a week) and at the same time taking vitamin D supplement (6000 units per week).
Intervention group: 10 male smokers who did aerobic exercise for 4 weeks (running at more than 50% of maximum maximum heart rate, 3 days a week).
Intervention group: 10 male smokers who took vitamin D supplement (6000 units per week) for 4 weeks. Control group: did not have any activity or supplementation during 4 weeks of intervention.
Main outcome variables
Tumor necrosis factor alpha (TNF-α), Interleukin-6 (IL-6), Clara protein (CC16), Surfactant-D protein (SP-D) and Lung function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039637N4
Registration date:2020-10-20, 1399/07/29
Registration timing:retrospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Hadi Pourmanaf
Name of organization / entity
Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 41 3656 1262
Email address
hadi.pvrmnaf@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
2020-09-10, 1399/06/20
Actual recruitment end date
2020-10-11, 1399/07/20
Trial completion date
2020-10-11, 1399/07/20
Scientific title
The effect of vitamin D supplementation and aerobic exercise on serum levels of inflammatory factors and lung function in male smokers
Public title
The effect of vitamin D supplementation and aerobic exercise on inflammation and lung function in male smokers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least one year of smoking history
Being male
Healthy
Exclusion criteria:
Having a history of diabetes
Having a history of cardiovascular disease
Having food allergies
Having a history of respiratory disease
Use a sports supplement before or during the study
Use the drug before or during the study
Use of inflammatory agents before or during the study
Age
From 24 years old to 38 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization, individuals were divided into 4 homogeneous groups (endurance training + vitamin D, endurance training, vitamin D and control). The randomization tool was also sealed in the envelope. The randomization unit was also individual. Number 1 in the envelope showed the subjects in the endurance training group + vitamin D, number 2 showed the endurance training group, number 3 showed the training group of vitamin D and number 4 showed the control group. And there was no concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Commitee for Ethics in Biomedical Research
Street address
Iran National Committee for Ethics in Biomedical Research, Iran TV Street., Qods Town
City
Tehran
Province
Tehran
Postal code
0000000000
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.TBZMED.REC.1399.727
Health conditions studied
1
Description of health condition studied
Dose not apply
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum levels of interleukin 6 (IL-6) in male smokers
Timepoint
Blood sampling one day before the intervention and 24 hours after the intervention (2 stages)
Method of measurement
Interleukin6 Kit
2
Description
Serum Tumor necrosis factor alpha (TNF-α) levels in male smokers
Timepoint
Blood sampling one day before the intervention and 24 hours after the intervention (2 stages)
Method of measurement
TNF-α kit
3
Description
Serum levels of Clara cell protein (CC16) in male smokers
Timepoint
Blood sampling one day before the intervention and 24 hours after the intervention (2 stages)
Method of measurement
CC16 kit
4
Description
Serum levels of surfactant protein-D (SP-D) in male smokers
Timepoint
Blood sampling one day before the intervention and 24 hours after the intervention (2 stages)
Method of measurement
SP-D kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 male smokers who did endurance training for 4 weeks (running, 3 days a week with an intensity above 50% of maximum heart rate) and took vitamin D supplement (1000 units per week) with it. In this study, the supplement of the British company Health Aid was used.
Category
Other
2
Description
Intervention group: 10 male smokers who did endurance training for 4 weeks (running, 3 days a week with an intensity above 50% of maximum heart rate).
Category
Other
3
Description
Intervention group: 10 male smokers who took vitamin D supplements (1000 units per week) for 4 weeks. In this study, the supplement of the British company Health Aid was used.
Category
Other
4
Description
Control group: 10 male smokers who did not have endurance training during the intervention (4 weeks) and did not take supplements.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital in Tabriz
Full name of responsible person
هومن ناطقیان
Street address
Shafa alley, Azadi boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3662 6861
Email
hoomannt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
leila nikniaz
Street address
No. Azadi Alvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3662 6861
Email
Nikniazleila@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Hadi pourmanaf
Position
Master Educated
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 497, Banafsheh alley, Valliamr boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 914 972 2862
Email
hadipourmanaf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi pourmanaf
Position
master educated
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 497, Banafsheh alley, Valliamr boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3662 6861
Email
hadipourmanaf@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadipourmanaf@gmail.com
Position
master educated
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 497, Banafsheh alley, Valliamr boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3662 6861
Email
hadipourmanaf@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
En In adress: Sportdezh.rzb.ir
When the data will become available and for how long
every time
To whom data/document is available
every one
Under which criteria data/document could be used
Modeling of the subject, supplementation method and training method is allowed
From where data/document is obtainable
Send an email to hadipourmanaf@yahoo.com or visit Sportdezh.rzb.ir.
What processes are involved for a request to access data/document
Send an email to hadipourmanaf@yahoo.com or visit Sportdezh.rzb.ir.