Alterations of short-term vitamin D supplementation on the antioxidant capacity and muscle damage indicators responses to exhausting aerobic activity in non-athletic men
The effect of short-term vitamin D supplementation on the antioxidant capacity and muscle damage indicators responses to exhausting aerobic activity in non-athletic men
Design
The present study is a randomized double-blind clinical trial with control group on men overweight.
Settings and conduct
30 samples were divided into experimental group (vitamin D recipient) and placebo (oral paraffin recipient) using a randomized permuted block method. every groups received diet using adjusted ideal body weight. Macronutrient distribution in diet will be given in the form of 65-45% CHO, 10-15% and 30-35% fat. In this study, there are 2 visits for the patient at the beginning, and the end of the study. This study was conducted in the form of double-blind that patients and physicians and investigators be unaware of the type of intervention that they were taking.
Participants/Inclusion and exclusion criteria
Men 20 to 30 years/overweight; no use of any drug and / or surgical treatment; Not having any systemic disease and other endocrine disorders
Intervention groups
In this study, one group receiving vitamin D as intervention group and one group receiving oral paraffin as a control group.
Main outcome variables
Anthropometric indices, liver enzymes, antioxidant capacity, muscle damage, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210414050965N1
Registration date:2021-05-04, 1400/02/14
Registration timing:prospective
Last update:2021-05-04, 1400/02/14
Update count:0
Registration date
2021-05-04, 1400/02/14
Registrant information
Name
Vahid Parvizi
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3841 6287
Email address
vahidparvizi1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Alterations of short-term vitamin D supplementation on the antioxidant capacity and muscle damage indicators responses to exhausting aerobic activity in non-athletic men
Public title
The effect of short-term vitamin D supplementation on the antioxidant capacity and muscle damage indicators responses to exhausting aerobic activity in non-athletic men
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight men
Age 20 to 30 years
Body mass index above 25 to 29.99
Vitamin D deficiency (25 levels of hydroxyvitamin D below 30 nanomoles / liter)
Exclusion criteria:
Muscle injury
Uncontrolled intake of vitamin D supplements
Doing regular exercise
smoking
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were classified using randomized block splitting and divided into two groups using random numbers table. Each participant will have an equal chance of being in each group, and researchers and participants in the study will not be able to predict the type of intervention they receive.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients were randomly divided into two groups who were informed about entering the study and were not aware of the type of intervention received. On the other hand, the researcher who does all the information and measurements is also unaware of the type of intervention that each patient receives. A collaborator physician in the study was also blinded to this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah Razi University
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.RAZI.REC.1400.001
Health conditions studied
1
Description of health condition studied
muscle damage indicators
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Antioxidant capacity
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling
2
Description
Muscle damage indicators
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling
3
Description
Serum levels of liver enzymes
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Fourteen subjects, Vitamin D supplementation (including receiving vitamin D from Zahravi Pharmaceutical Company, at the rate of 2000 units per day for six weeks), Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol.
Category
Lifestyle
2
Description
Control group: Control group: Fourteen subjects, Receive a placebo containing paraffin made by Zahravi Pharmaceutical Company of Iran (daily for six weeks) which is similar to vitamin D supplement in terms of shape, color, smell and taste. Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hosein hospital
Full name of responsible person
vahid parvizi mastali
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3431 1518
Email
vahidparvizi1996@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3267
Email
R.hoseini@Razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
Proportion provided by this source
10
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Razi Univeristy
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3267
Email
R.hoseini@razi.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
008334233267
Email
R.hoseini@razi.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
008334233267
Email
R.hoseini@razi.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be record in the SPSS software and will be available.
When the data will become available and for how long
Availability will start nine months after publishing all papers
To whom data/document is available
Only available for researchers in academic and scientific institutions
Under which criteria data/document could be used
All data can be used as reference
From where data/document is obtainable
vahidparvizi1996@gmail.com
What processes are involved for a request to access data/document
If the explanation for data request would be convincing it will be given in 3 days.