Effect of vitamin D supplementation on inflammatory markers, muscle damage indices, performance and body composition in athletes
Design
The study has a randomized, double-blind clinical trial design. It has case and control groups with a parallel group design of 100 participants, enrolled between June 2018 and August 2018.
Settings and conduct
The study is conducted at Arsham Health and Fitness Center in Isfahan. Blindness is done both for researchers and for participants. Blinding is conduct by placing the names A and B on the supplements given to the two groups. Until the end of the study and obtaining the results of statistical tests, the identities of the groups are not revealed to the researcher and participant.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants should exercise 30 minute at least thrice weekly for one year ago
exclusion criteria: the existence of diseases; Participants whose smoke: take anti-inflammatory medication (such as aspirin, ibuprofen, acetaminophen); nutritional supplements
Intervention groups
In this study, the intervention group received a vitamin D supplemented per week for 8 weeks, including 50,000 international units of vitamin D3 (Dana pharmaceutical company, Tabriz)
The control group also has received placebo in same of shape, color, and size with the vitamin supplement for the 8 weeks
Effect of vitamin D supplementation on inflammatory markers, muscle damage indices, performance and body composition in athletes
Public title
effect of vitamin D on athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants should exercise 30 minute at least thrice weekly for one year ago
Exclusion criteria:
the existence of pathologies diseases
Participants whose smoke
take anti-inflammatory medication (such as aspirin, ibuprofen and acetaminophen)
Consumption nutritional supplements
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will conduct using permuted block random of size 2. Random numbers generated in statistical software and participants divide into the intervention and placebo groups. For this purpose we consider the smaller number as an intervention group and the larger number as the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, to avoid bias we will use supplements and placebo completely in same of shape, color, and size. Supplements and placebo can be distinguished by the letters of the English alphabet. Participants and researchers will not be aware of these codes until the end of the study. Data collectors and statistical specialist who assess the outcomes divide only two groups with English letters. At the end of the evaluations and conclusions for the final report of the study as an article, the codes of two groups are identified for the researchers by the company producing the supplement and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Mullasadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.BMSU.REC.1396.331
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Alanine aminotransferase serum level
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
By enzymatic photometric method (IFCC) with a sensitivity of 2 U / L and a coefficient of variation of 14% will be determined.
2
Description
Aspartate aminotransferase serum level
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
By enzymatic photometric method (IFCC) with a sensitivity of 2 U / L and a coefficient of variation of 14% will be determined.
Secondary outcomes
1
Description
Serum level of vitamin D
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
will be measured by direct competitive immune assay
2
Description
Serum level of lactate dehydrogenase
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
By enzymatic chlorometric method with U / L 5 sensitivity and a change coefficient of 2.1% will be determined.
3
Description
exercise heart rate
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Measurement are taken from the radial artery with forefinger and the middle finger of the right hand placed horizontally
Intervention groups
1
Description
In this study, the intervention group received a vitamin D supplemented per week for 8 weeks, including 50,000 international units of vitamin D3 (Dana pharmaceutical company, Tabriz)
Category
Treatment - Other
2
Description
The control group also has received placebo in same of shape, color, and size with the vitamin supplement for the 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arsham fitness center
Full name of responsible person
Mahmood Tabesh
Street address
Arsham fitness center, Hojjati Street, Najaf Abad, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8515644574
Phone
+98 31 4272 3369
Email
mahmoudtabesh7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hosein Rostami
Street address
Baqiyatallah University of Medical Sciences, Mullasadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
Email
hosein_rostami59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hamid Zolfaghari
Position
Nutritionist
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Baqiyatallah University of Medical Sciences, Mullasadra Street, Vanak Square,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
Email
h.z.7025@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hamid Zolfaghari
Position
Nutritionist
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Baqiyatallah University of Medical Sciences, Mullasadra Street, Vanak Square,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
Email
h.z.7025@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hamid Zolfaghari
Position
Nutritionist
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Baqiyatallah University of Medical Sciences, Mullasadra Street, Vanak Square,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
Email
h.z.7025@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
Not applicable
Title and more details about the data/document
The data is related to the main outcome of study can be shared
When the data will become available and for how long
Six months after publishing article of study
To whom data/document is available
Researchers at universities
Under which criteria data/document could be used
Only to verify the accuracy of the data and getting to know with the measurement values can be used. All data analysis rights are reserved for the owners of the project to publishing articles.
From where data/document is obtainable
Applicants can email this address
H.Z.7025@gmail.com
What processes are involved for a request to access data/document
After ensuring the applicant's membership as a faculty member of one of the academic centers, information will be sent to his academic email.