Determining the effect of acetazolamide on the athletic performance of male physical education students at the simulated height
Design
This research project will include 14 male students of physical education at Razi University. This study has 2 groups, one group will use acetazolamide, and the other group will use a placebo. This research is one of the laboratory researches in which double-blind, randomized block studies will be performed using Random allocation software with intra-group design and mutual balance And has a clinical trial phase 3
Settings and conduct
This study will be performed in Kermanshah city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Students aged 18 to 29 at Razi University; Body mass index 18 to 24.
Exclusion criteria:
Permanent residence at altitudes above 2000 meters;
History of cognitive disorders or neurological diseases;
Having a chronic illness;
Smoking;
History of living at altitudes of more than 2000 meters in the two months before the start of a research.
Intervention groups
Supplement group: acetazolamide Control group: placebo
Main outcome variables
Evaluation of endurance sports performance at simulated heights;
Evaluation of arterial oxygen saturation at simulated altitude;
Evaluate the perceived pressure at the simulated height;
Heart rate assessment at simulated altitude.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170326033146N6
Registration date:2021-04-08, 1400/01/19
Registration timing:prospective
Last update:2021-04-08, 1400/01/19
Update count:0
Registration date
2021-04-08, 1400/01/19
Registrant information
Name
Vahid Tadibi
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 9265
Email address
vahidtadibi@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acetazolamide on exercise performance of male physical education students in simulated altitude
Public title
The effect of acetazolamide on athletic performance at height
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male student of Razi University
18 to 29 years old
BMI: 18.5 - 29.4
Exclusion criteria:
Permanent residence at altitudes above 2000 meters
History of cognitive disorders or neurological diseases
Having a chronic illness
Smoking
History of living at altitudes of more than 2000 meters in the two months before the start of a research
Age
From 18 years old to 29 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Someone other than the researchers will use the random allocation software for the allocation of the subjects by a randomized blocking method. During the process of allocation, each subject will be given a unique identification code that will be given to the main researchers together with the necessary treatment (Acetazolamide or placebo). The identification code will be used as a label to identify the group of each subject for data analysis after completion of the study. The random allocation software program can generate block randomization. The sample size and the name of the two groups (Acetazolamide and placebo) will be defined in the randomization main menu of the software. Then, the block design will be entered as equal size. Also, the format of the unique identification code will be defined as alphanumeric with fixed length. The last step is to generate the random list in which each entry in the list consists of a unique identification code and a group name.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because this study is double-blind, the subjects and researchers will not know who take acetazolamide or placebo, and someone else will assess the results. Also, medications will be prepared in the similar capsules, and the placebo group will use lactose powder.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah Razi University
Street address
Tagh-e-Bostan, University St.
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.RAZI.REC.1399.071
Health conditions studied
1
Description of health condition studied
Hypoxia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Endurance training performance
Timepoint
The beginning of the study to assess the level of endurance function after taking acetazolamide or placebo and after hypoxia.
Method of measurement
The Astrand test for men is used to measure the maximum power output of the subjects.
Secondary outcomes
empty
Intervention groups
1
Description
Supplementary group: First, a cognitive function test will be performed. 48 hours later, subjects will take 2 doses of 125 mg and another dose the next morning of acetazolamide. The Astrand test will be then performed, and hypoxia will be induced immediately, and the test will be repeated. A one-week wash out period will be considered.
Category
Prevention
2
Description
Placebo group: First, a cognitive function test will be performed. 48 hours later, subjects will take 2 doses of 125 mg and another dose the next morning. The Astrand test will be then performed, and hypoxia will be induced immediately, and the test will be repeated. A one-week wash out period will be considered.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi university
Full name of responsible person
Mohammad Khazaie
Street address
Razi University, Shahid Ashrafi Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
46715-65981
Phone
+98 83 3427 7887
Email
razimohammadkhazaie1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzad Veisi
Street address
Deputy of Research and Technology, Razi University, University St., Tagh-e-Bostan,
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
veysi@razi.ac.ir
Web page address
https://are.razi.ac.ir/%D8%B5%D9%81%D8%AD%D9%87-1
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
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
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Sciences, Razi University, University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Web page address
https://phe.razi.ac.ir/~vahidtadibi
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Sciences, Razi University, University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Science, Razi University< University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All Data
When the data will become available and for how long
assess ability immediately after publication of the results
To whom data/document is available
Researchers
Under which criteria data/document could be used
For meta analysis
From where data/document is obtainable
Vahid Tadibi vtadibi@yahoo.com
What processes are involved for a request to access data/document