Determining the effect of acetazolamide on cognitive function in normobaric hypoxia in male students of Razi University
Design
counterbalanced within-subject design
Settings and conduct
This study will be performed in Kermanshah city.
Participants/Inclusion and exclusion criteria
Students aged 18 to 29 at Razi University
Body mass index 18 to 24
Intervention groups
Supplement group: the group that will take acetazolamide. Control group: the group that will take a placebo.
Main outcome variables
Evaluation of cognitive function in hypoxia with and without acetazolamide
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170326033146N5
Registration date:2021-03-24, 1400/01/04
Registration timing:prospective
Last update:2021-03-24, 1400/01/04
Update count:0
Registration date
2021-03-24, 1400/01/04
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
2021-04-04, 1400/01/15
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acetazolamide on cognitive function of male students in normobaric hypoxia
Public title
The effect of acetazolamide on cognitive function in hypoxia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male student of Razi University
Age 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
Half of the participants will take acetazolamide in the first week, and the other half will take a placebo in the second week. The order of supplementation and placebo for the subjects will be random.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, neither the participant nor the researcher knew about the supplement (acetazolamide or placebo).
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
6714414971
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.RAZI.REC.1399.067
Health conditions studied
1
Description of health condition studied
Normobaric hypoxia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Simple visual reaction time
Timepoint
The beginning of the study to assess the level of cognitive function after taking acetazolamide or placebo and after hypoxia.
Method of measurement
Cognitive function is assessed using a reaction time device. ( RESPONSE PANEL63035A, LAFAYETTE, INDIANA )
2
Description
Simple auditory reaction time
Timepoint
The beginning of the study to assess the level of cognitive function after taking acetazolamide or placebo and after hypoxia.
Method of measurement
Cognitive function is assessed using a reaction time device. ( RESPONSE PANEL63035A, LAFAYETTE, INDIANA )
3
Description
Selective visual reaction time
Timepoint
The beginning of the study to assess the level of cognitive function after taking acetazolamide or placebo and after hypoxia.
Method of measurement
Cognitive function is assessed using a reaction time device. ( RESPONSE PANEL63035A, LAFAYETTE, INDIANA )
Secondary outcomes
empty
Intervention groups
1
Description
First, the cognitive function test will be performed. Forty-eight hours later, they will take two doses of 125 mg and another dose the next morning, placebo or acetazolamide. The reaction time test is then performed, and immediately hypoxia is applied, and the test is repeated. Half of the participants took acetazolamide in the first week, and the other half took a placebo. A one-week wash-out period will be considered. Then, in the second week, people took acetazolamide to take a placebo, and vice versa.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi university
Full name of responsible person
Vahid Solgi
Street address
Razi University, Shahid Ashrafi Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
46715-65981
Phone
+98 83 3427 7887
Email
vsolgi13590@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
Web page address
https://phe.razi.ac.ir/~vahidtadibi
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
Web page address
https://phe.razi.ac.ir/~vahidtadibi
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