Effects of vitamin D supplementation on serum levels of adipose tissue browning endocrine regulators, anabolic hormone and exercise performance in male athletes
Determining the effects of vitamin D supplementation on serum levels of adipose tissue browning endocrine regulators, anabolic hormone and exercise performance in male athletes
Design
This study will be conducted as a randomized, double blind clinical trial with two parallel groups.
Settings and conduct
The present study will be conducted on 42 physical education students of Shahid Chamran University, which have regular physical activity.
Participants/Inclusion and exclusion criteria
Inclusion criteria are as below:
Age more than 18 years; Male gender; Intention to participate; BMI between 18.5 to 29.9; Vo2max equal to 40 to 60 ml/kg/min; Regular physical activity for at least three times per week each time
Exclusion criteria are as below:
No intention to participate; Presence of any metabolic diseases; Presence of diagnosed renal (acute or chronic) and bone disease; Smoking; Using other supplements at the beginning of the study or during past 3 months
Intervention groups
Athletes receive the appropriate supplements depending on the intervention or placebo group for 8 weeks. participants in the intervention group receive a vitamin D3 tablet with an 2000 IU dose of Zahrawi Company. Also, people in the placebo group receive a placebo tablet containing maltodextrin that looks like vitamin D supplement.
Main outcome variables
Primary outcomes of this study include serum levels of endocrine regulators of white adipose tissue browning (FGF-21, BMP-4, IL-15 and meteorin-like); anabolic hormones (growth hormone, IGF-1, testosterone) and athletic performance (aerobic and anaerobic performance).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131117015424N3
Registration date:2018-06-07, 1397/03/17
Registration timing:prospective
Last update:2018-06-07, 1397/03/17
Update count:0
Registration date
2018-06-07, 1397/03/17
Registrant information
Name
MAjid Mohamadshahi
Name of organization / entity
Ahvaz Jundishapur University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 439 2836
Email address
mohamadshahi-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation on serum levels of adipose tissue browning endocrine regulators, anabolic hormone and exercise performance in male athletes
Public title
Effects of vitamin D on athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Intention to participate
BMI between 18.5 to 29.9
Vo2max between 40-60 ml/kg/min
Regular physical activity for at least three times per week each time
Exclusion criteria:
No intention to participate
Presence of metabolic diseases
Presence of diagnosed renal (acute or chronic) and bone disease
Smoking
Using other supplements at the beginning of the study or during past 3 months
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will randomly assigned into two groups receiving either vitamin D supplements or a placebo group,with using random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, participants and researcher will be blinded to the studying groups. Prior to the study, the cans containing the respective pills will be coded by a person other than the researcher to A and B so that the type of received pills in each group will be blinded for researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapour University of Medical Science
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.AJUMS.REC.1397.012
Health conditions studied
1
Description of health condition studied
Athletes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum levels of Fibroblast Growth Factor-21
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
2
Description
Serum levels of Bone morphogenetic protein 4
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
3
Description
Serum levels of meteorin-like
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
4
Description
Serum levels of interleukin-15
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
5
Description
Serum levels of Growth hormone
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
6
Description
Serum levels of Insulin-like growth factor 1
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
7
Description
Serum levels of testosterone
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
8
Description
Aerobic performance
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
By estimating the maximal oxygen uptake (Vo2 max) using the Bruce test
9
Description
Anaerobic performance
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Be determined on the basis of 30-second Wingate test using a Monark bike
Secondary outcomes
1
Description
Serum levels of cortisol
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
2
Description
Serum levels of Parathyroid hormone
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
3
Description
Serum levels of 25-hydroxy vitamin D
Timepoint
pre-intervention and after 12 weeks of intervention.
Method of measurement
Using enzyme-linked immunosorbent assay (ELISA) kit
Intervention groups
1
Description
Intervention group: Daily intake of vitamin D supplement with a dose of 2000 international unit of Zahrawi company (Iran) for 12 weeks
Category
Treatment - Other
2
Description
Control group: Daily intake of a placebo that look likes vitamin D supplement and contains maltodextrin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Physical Education, Shahid Chamran University of Ahvaz, Ahvaz, Khuzestan Province
Full name of responsible person
Aliakbar Alizadeh
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 0011
Fax
Email
Oisc@scu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 1984
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Mohamadshahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 912 439 2836
Fax
+98 61 1333 7079
Email
mohamadshahi-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Mohamadshahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 912 439 2836
Fax
+98 61 1333 7079
Email
mohamadshahi-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Mohamadshahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 912 439 2836
Fax
+98 61 1333 7079
Email
mohamadshahi-m@ajums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data related to outcomes of the study will be published in the article as a comparison between groups.
When the data will become available and for how long
Data will be available 6 months after publication.
To whom data/document is available
Access to this information will be allowed for researchers and people involved in their work with athletes (such as sports coaches or professional athletes).
Under which criteria data/document could be used
Data will not be available for analysis to other people, but the study protocol, the method of analysis and the final results will be presented so that people are aware of the correctness of the method of study.
From where data/document is obtainable
You can refer to the Department of Nutrition Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, or email shahi334@gmail.com to receive the documentation.
What processes are involved for a request to access data/document
If the applicant's request is announced in accordance with the terms, it can be sent to the person within one week.