Protocol summary

Summary
study aims: Regarding to avoid of compromising the immune system after exhaustive exercise and the role of micronutrients in this background, the aim of this study was to investigate the effect of vitamin C supplementation on the salivary immunoglobulin A, cortisol and total protein concentration on active girls college following exhaustive physical activity program. Inclusion Key criteria was that must participants be athlete and not suffering the common cold,exclusion Key criteria have been that subjects be involving common cold, The study population girl students of Lorestan University of Physical Education and the sample size were in the first of the twenty-four that participated voluntarily Then, was reduced to seventeen sample size because of loss of participants during performances and randomly assigned into three groups: exercise - vitamin C supplementation (n=6), exercise (n=5) and control group (n = 6). exercise - vitamin C supplementation group perform study physical activity program for7 days in AM and PM, with receive 500 mg vitamin C tablets in a fasting term daily, exercise groups performed same protocol without supplementation receive, and the control group performed neither the physical activity nor received the supplement. Saliva samples were collected one day before starting the physical activity program and also 24 and 72 hours after the last session, in 9/30 morning then The factors immunoglobulin A, cortisol and salivary total protein were measured that are as the primary outcome variable of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016063028429N2
Registration date: 2016-07-07, 1395/04/17
Registration timing: na

Last update:
Update count: 0
Registration date
2016-07-07, 1395/04/17
Registrant information
Name
Mohammd Fathi
Name of organization / entity
Lorestan University
Country
Iran (Islamic Republic of)
Phone
+98 916 397 2041
Email address
fathi.m@lu.ac.ir
Recruitment status
Not enough for processing
Funding source
Investigator
Expected recruitment start date
2016-02-27, 1394/12/08
Expected recruitment end date
2015-08-09, 1394/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin C supplementation on the salivary immunoglobulin A, cortisol and total protein concentrations following an exhaustive training program
Public title
The effect of vitamin C on the mucosal immune system
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: athletes (at least have 8 hours per week of physical activity ; female; non suffering a common cold and specific diseases Exclusion criteria: suffering a common cold during the execution of the training program
Age
From 20 years old to 29 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 17
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan University
Street address
Lorestan University
City
Khoramabad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
5974

Health conditions studied

1

Description of health condition studied
Certain diseases have not been studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
IgA
Timepoint
Three times before the program, 24 and 72 hours after application
Method of measurement
Saliva samples

2

Description
Cortisol
Timepoint
Three times before the program, 24 and 72 hours after application
Method of measurement
Saliva samples

3

Description
Total protein
Timepoint
Three times before the program, 24 and 72 hours after application
Method of measurement
Saliva samples

Secondary outcomes

empty

Intervention groups

1

Description
control group performed neither the physical activity nor received the supplement
Category
Prevention

2

Description
exercise - vitamin C supplementation group perform study physical activity program for7 days with receive 500 mg vitamin C tablets in a fasting term daily
Category
Prevention

3

Description
exercise groups performed protocol without supplementation receive
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Lorestan University
Full name of responsible person
Mohammad Fathi
Street address
Lorestan University
City
Khormabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University
Full name of responsible person
Mohammad Fathi
Street address
Lorestan University
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University
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
Lorestan University
Full name of responsible person
Mohammad Fathi
Position
Assistant Professor, Physical Education Department, Humanity Faculty, Lorestan University
Other areas of specialty/work
Street address
Lorestan University
City
Khoramabad
Postal code
Phone
00
Fax
+98 938 920 5366
Email
javidfathi@gmail.comm_fathi723@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University
Full name of responsible person
Mohammad Fathi
Position
Assistant Professor, Physical Education Department, Humanity Faculty, Lorestan University
Other areas of specialty/work
Street address
Lorestan University
City
Khoramabad
Postal code
Phone
00
Fax
+98 938 920 5366
Email
javidfathi@gmail.comm_fathi723@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University
Full name of responsible person
Mohammad fathi
Position
Assistant Professor of Lorestan University
Other areas of specialty/work
Street address
Lorestan University
City
Khoramabad
Postal code
Phone
00
Fax
+98 938 920 5366
Email
javidfathi@gmail.comm_fathi723@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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