The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes
Design
Clinical trial with control group and supplement group, double-blind, randomized, phase 3 on 14 patients, Excel software was used to evaluate the data.
Settings and conduct
Aerobic capacities of the participants will be measured using the Bruce test and the use of a gas analyzer (Gas Analyzer: Cortex Biophysic Germany), which will be manually entered into the treadmill data. In this way, after installing the device's heart rate sensor on the subject's chest and identifying it by the device, the subject's information including age and weight is entered and finally the Bruce test begins and the person performs the test with increasing intensity until the time of exhaustion. The end of maximum oxygen consumption of people is calculated and recorded by the device. The intervention with iron or placebo begins after measuring the research variables and continues for 3 weeks, and after the end of the three-week period, the subjects are re-tested. Both researchers and participants were blinded.
Participants/Inclusion and exclusion criteria
Completing the informed consent form and having full consent, not having any types of special and chronic diseases, the type and time of drug use (if used), not having pain in a specific area of the body
Intervention groups
Supplemental group: daily recipient of 100 mg of iron (a 100 mg tablet of polymaltose iron trihydroxide complex) for 3 weeks
Control group: receiving 100 mg of placebo daily (two mouth deodorizing tablets that are the same color and shape as iron tablets and are completely ineffective) for 3 weeks
Main outcome variables
Maximum aerobic power, pressure perception scale, time to reach stasis, pulmonary ventilation and respiratory efficiency including EQO2 and EQCO2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230816059165N1
Registration date:2023-11-04, 1402/08/13
Registration timing:retrospective
Last update:2023-11-04, 1402/08/13
Update count:0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Ghazal Safa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4220 7370
Email address
ghazal.safa94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-08, 1401/03/18
Expected recruitment end date
2022-06-15, 1401/03/25
Actual recruitment start date
2022-06-22, 1401/04/01
Actual recruitment end date
2022-06-30, 1401/04/09
Trial completion date
2022-08-24, 1401/06/02
Scientific title
The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes
Public title
The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Completing the informed consent form and having full consent to participate in the current research
Not having a variety of special and chronic diseases
Not having pain in a particular area of the body
Type and time of drug administration (if used)
Exclusion criteria:
Age
From 16 years old to 33 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Actual sample size reached:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method with individual randomization unit: In this way, the 14 subjects of the present study were divided into two groups of 7 by the laboratory manager without considering any specific case among them.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, the subjects had no information about which of the two iron supplement and placebo groups they had taken, and they were kept blind in the study.
The administration of the supplement and placebo was done by the laboratory official taking into account ethical considerations, so that they knew which package contained iron and which one contained placebo, and gave iron supplement to one group and placebo to another group. Is. After this step was done, only the researcher and supervisor were informed.
The doctor in charge of the present study has also approved the permission to use iron supplements and has been involved in all stages of the work.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University Research Ethics Committee
Street address
No. 54, Saadi St., Khajoo Crossroad; Sirjan
City
Sirjan
Province
Kerman
Postal code
7814615431
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.US.REC.1401.023
Health conditions studied
1
Description of health condition studied
The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Investigating the percentage of changes and significant differences between the two studied groups in the aerobic capacity of female handball players
Timepoint
Measuring blood volume of the participants before the intervention and 21 days after consuming 100 mg of iron (a 100 mg tablet of polymaltose iron trihydroxide complex)
Method of measurement
Maximum aerobic capacity, pressure perception scale, time to reach paralysis, lung ventilation and respiratory efficiency including EQO2 and EQCO2 using Bruce test and using gas analyzer (Gas Analyzer: Cortex Biophysik Germany) which will be entered manually in the treadmill data. is measured and at the end the aerobic capacities of people are calculated and recorded by the device.
Secondary outcomes
1
Description
No significant difference was observed between the two studied groups in respiratory indices (Vo2max; RPE; VE; TTE; EQO2; EQCO2).
Timepoint
Measuring blood volume of the participants before the intervention and 21 days after consuming 100 mg of iron (a 100 mg tablet of polymaltose iron trihydroxide complex)
Method of measurement
Maximum aerobic capacity, pressure perception scale, time to reach paralysis, lung ventilation and respiratory efficiency including EQO2 and EQCO2 using Bruce test and using gas analyzer (Gas Analyzer: Cortex Biophysik Germany) which will be entered manually in the treadmill data. is measured and at the end the aerobic capacities of people are calculated and recorded by the device.
Intervention groups
1
Description
Intervention group: daily intake of 100 mg of elemental iron (one 100 mg tablet of polymaltose iron trihydroxide complex for 3 weeks), every night 1 hour before sleep. Manufacturer: Viralian Group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz women's handball team
Full name of responsible person
Ghazal Safa
Street address
No. 54, Saadi St., Khajoo Crossroad., Sirjan
City
Sirjan
Province
Kerman
Postal code
7814615431
Phone
+98 34 4220 7370
Email
ghazal.safa94@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Shiraz
Full name of responsible person
Ghazal Safa
Street address
No. 54, Saadi St., Khajoo Crossroad., Sirjan
City
Sirjan
Province
Kerman
Postal code
7814615431
Phone
+98 34 4220 7370
Email
ghazal.safa94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Shiraz
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
The University of Shiraz
Full name of responsible person
Ghazal Safa
Position
Fitness Trainer
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 54, Saadi St., Khajoo Crossroad., Sirjan
City
Sirjan
Province
Kerman
Postal code
7814615431
Phone
+98 34 4220 7370
Email
ghazal.safa94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shiraz
Full name of responsible person
Ghazal Safa
Position
Fitness Trainer
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 54, Saadi St., Khajoo Crossroad., Sirjan
City
Sirjan
Province
Kerman
Postal code
7814615431
Phone
+98 34 4220 7370
Email
ghazal.safa94@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Shiraz
Full name of responsible person
Ghazal Safa
Position
Fitness Trainer
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 54, Saadi St., Khajoo Crossroad., Sirjan
City
Sirjan
Province
Kerman
Postal code
7814615431
Phone
+98 34 4220 7370
Email
ghazal.safa94@gmail.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
Because of students' unauthorized use of data and data creation through other people's data, which ultimately devalues other people's research.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as the main outcome information, will be available only to researchers working in academic and scientific institutions after de-identifying individuals.
When the data will become available and for how long
The access period starts from June 2023
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers working in academic and scientific institutions can use only part of the data, such as the information related to the main outcome, in their scientific researches and refer to the results obtained from them, but the right of any new analysis on the delivered data, do not have.
From where data/document is obtainable
Full name of the researcher: Ghazal Safa/Gmail: ghazal.safa94@gmail.com
What processes are involved for a request to access data/document
Only a part of the data, such as the information related to the main outcome, will be sent to researchers working in academic and scientific institutions after receiving the e-mail from the researcher.