The effect of vitamin D in comparison with normal saline on the inflammatory changes and some biochemical factors during a weight training session in bodybuilders
The aim of this study is to investigate the effect of vitamin D injection on inflammatory and biochemical changes in vitamin D-deficient athletes during a bodybuilding training session. The study population consists of fourteen athletes presented to nutrition clinic. Athletes are screened based on the inclusion and exclusion criteria. The level of Vitamin D in each participant is measured. Subjects participate in the vitamin D-injected and normal saline-injected protocols with a 4-week period between injections. On the exercise day, fifteen minutes before starting exercise, a catheter is inserted into the peripheral vein and 5 ml blood sample is taken and then separated. Venous bloods are drawn before exercise, immediately after the exercise and one hour after exercise. Serum samples will be stored at -80 ˚C until assay. The secreted cytokines and hormonal levels are measured using commercially available ELISA kits. Biochemical biomarkers are determined by spectrophotometery method. All measurements will be performed in triplicate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102524699N1
Registration date:2016-05-08, 1395/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Damoon Ashtary-Larky
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 614436106
Email address
ashtary.d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
This project supports by a grant from Ahvaz Jundishapur University of Medical Sciences.
Expected recruitment start date
2015-08-14, 1394/05/23
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D in comparison with normal saline on the inflammatory changes and some biochemical factors during a weight training session in bodybuilders
Public title
The effect of vitamin D on inflammatory changes during exercise
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Male athletes aged 20 to 30 years; training for approximately 2 years; percentage of body fat in the normal range; without cardiovascular disease and muscular damage
Exclusion criteria: weight loss diet over the past month, consumption of any dietary and sport supplements 8 weeks before the study, having acute and chronic illnesses, 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:
14
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
This study is a clinical trial crossover design in which each subject serves
as their own control. How to blind? No athlete or examiner knows in what groups the athletes will be placed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.AJUMS.REC.1394.300
Health conditions studied
1
Description of health condition studied
Inflammatory conditions
ICD-10 code
R76.9
ICD-10 code description
Abnormal immunological finding in serum, unspecified
Primary outcomes
1
Description
Tumor necrosis factor alpha
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
ELISA - pg/ml
2
Description
Interleukin 10
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
ELISA - pg/ml
3
Description
Interleukin 6
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
ELISA - pg/ml
4
Description
Insulin
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
ELISA - mcU/ml
5
Description
C-peptide
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
ELISA - ng/ml
6
Description
Vitamin D
Timepoint
Before intervention; before workout
Method of measurement
ELISA - ng/ml
7
Description
Creatine kinase
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
Enzymatic method - U/L
8
Description
Lactate dehydrogenase
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
Enzymatic method - U/L
9
Description
Blood sugar
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
Enzymatic method - mg/dl
10
Description
Percentage body fat
Timepoint
Before workout
Method of measurement
Body fat Analyzer
11
Description
Blood pressure
Timepoint
Before workout; immediately after workout; one hour after workout
Method of measurement
Blood pressure machine
Secondary outcomes
empty
Intervention groups
1
Description
Injection of vitaminD3, 300,000 international units, darou pakhsh, iran, batch No: 932
Category
Treatment - Drugs
2
Description
Injection of normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Otana Health and Fitness Center
Full name of responsible person
Damoon Ashtary-Larky
Street address
Otana Health and Fitness Center, Zeytoon Karmandi, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fereidoon Najafi
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Seyyed Ali Mard
Position
Ph.D of physiology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
Phone
+98 916 611 8532
Fax
Email
alimard77@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Damoon Ashtary-Larky
Position
Msc. student of clinical biochemistry
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3443 6106
Fax
Email
damoon_ashtary@yahoo.com; ashtary.d@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Damoon Ashtary-Larky
Position
Msc. student of clinical biochemistry
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
Phone
+98 936 611 3574
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)