Sports AnemiaNCT05707455
Hematological Factors and Iron Status in Aerobic Versus Anaerobic Training in Athletic Females
An observational study of Sports Anemia, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the hematological factors and iron status in aerobic versus anaerobic training in athletic females. Read more about this study
- Who is it for?
- Ages 16 to 19 years, women only
- Conditions the study is for
- Sports Anemia
- What is being tested?
- evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- Women only
- Child, Adult
Study population: They were chosen via advertisement in local Cairo clubs.
Who may be able to join
- Healthy, virginal, nonsmoker, female athletes.
- Age from 16 to 19 years.
- Body mass index < 25 kg/m2.
- Having the same socio-economic level.
- Following a normal balanced nutrition.
Who cannot join
- Using any medical or hormonal therapy that might influence the iron status.
- Vegetarian athletes.
- Having menorrhagia or amenorrhea.
- Chronic inflammatory condition or existing infection.
- Diabetic, hypertensive or cardiac athletes.
- Haematological disease (with the exception of iron deficiency with or without anaemia).
- Having transfusion of blood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hematological Factors and Iron Status in Aerobic Versus Anaerobic Training in Athletic Females: An Observational Study
This study aimed to evaluate the hematological factors and iron status in aerobic versus anaerobic training in athletic females.
Read the detailed description
In both the short and long term, physical training causes iron status deterioration in sporty females. Nonetheless, little is known about the effect of different forms of exercise (aerobic versus anaerobic) on haematological variables and iron status in sporty females during adolescence. As a result, the purpose of this study was to compare the haematological variables and iron status in aerobic versus anaerobic exercise in adolescent female athletes. Another goal was to compare aerobic and anaerobic groups in terms of iron status classifications, such as normal iron status, iron deficiency with or without anaemia.
- Conditions
- Sports Anemia
- Being tested
- evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.
- Keywords
- Hematological factors, iron status, aerobic, anaerobic, athletic females, adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.Other
evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic group | long distance runners Receives: Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin. | |
| Anaerobic group | broad jumpers Receives: Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hemoglobin (Hb)
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hemoglobin (Hb).
Measured: 2 months
Assessment of hematocrit (Hct)
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hematocrit (Hct).
Measured: 2 months
Assessment of red blood cell (RBC) count
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure red blood cell (RBC) count.
Measured: 2 months
Assessment of mean corpuscular volume (MCV)
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular volume (MCV).
Measured: 2 months
Assessment of mean corpuscular hemoglobin concentration (MCHC)
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular hemoglobin concentration (MCHC).
Measured: 2 months
Assessment of serum transferrin
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum transferrin was measured using COBAS Integra 400 plus, Switzerland.
Measured: 2 months
Assessment of serum ferritin
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum ferritin was measured using ADVIA Centaur XPT, Germany.
Measured: 2 months
Secondary outcomes (4)
Anthropometric measures
A weight-height scale was used to assess the weight (Kg) and height (m) for each female athlete in the two groups. The body mass index (BMI) was then calculated by dividing the weight by the height squared (Kg/m2).
Measured: 2 months
Assessment of participation age to sport
Each female athlete was asked about her age of participation to sport to assess her training profile.
Measured: 2 months
Assessment of number of hours of training per week
Each female athlete was asked about the number of hours of training per week to assess her training profile.
Measured: 2 months
Assessment of training experience
The training experience in years was calculated by subtracting the female athlete's age of participation to training from her chronological age.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Sep 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports AnemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Doaa A Osman, Assis. Prof., Principal investigator, Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707455
- Sponsor's protocol ID
- P.T.REC/012/004727
- Status last verified
- Sep 2023
- First submitted
- 20 Jan 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological Factors and Iron Status in Aerobic Versus Anaerobic Training in Athletic Females: An Observational Study
- ClinicalTrials.gov ID
- NCT05707455
- Acronym / sponsor ID
- P.T.REC/012/004727
- Conditions
- Sports Anemia
- Keywords
- Hematological factors, iron status, aerobic, anaerobic, athletic females, adolescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the hematological factors and iron status in aerobic versus anaerobic training in athletic females.
Detailed description
In both the short and long term, physical training causes iron status deterioration in sporty females. Nonetheless, little is known about the effect of different forms of exercise (aerobic versus anaerobic) on haematological variables and iron status in sporty females during adolescence. As a result, the purpose of this study was to compare the haematological variables and iron status in aerobic versus anaerobic exercise in adolescent female athletes. Another goal was to compare aerobic and anaerobic groups in terms of iron status classifications, such as normal iron status, iron deficiency with or without anaemia.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic group | – | Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.long distance runners |
| Anaerobic group | – | Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.broad jumpers |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- They were chosen via advertisement in local Cairo clubs.
Key inclusion criteria (5 listed)
- Healthy, virginal, nonsmoker, female athletes.
- Age from 16 to 19 years.
- Body mass index < 25 kg/m2.
- Having the same socio-economic level.
- Following a normal balanced nutrition.
Key exclusion criteria (7 listed)
- Using any medical or hormonal therapy that might influence the iron status.
- Vegetarian athletes.
- Having menorrhagia or amenorrhea.
- Chronic inflammatory condition or existing infection.
- Diabetic, hypertensive or cardiac athletes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin. | Other | Aerobic group, Anaerobic group |
Primary outcome
Assessment of hemoglobin (Hb)
Time frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hemoglobin (Hb).
Assessment of hematocrit (Hct)
Time frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hematocrit (Hct).
Assessment of red blood cell (RBC) count
Time frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure red blood cell (RBC) count.
Assessment of mean corpuscular volume (MCV)
Time frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular volume (MCV).
Assessment of mean corpuscular hemoglobin concentration (MCHC)
Time frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular hemoglobin concentration (MCHC).
Assessment of serum transferrin
Time frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum transferrin was measured using COBAS Integra 400 plus, Switzerland.
Assessment of serum ferritin
Time frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum ferritin was measured using ADVIA Centaur XPT, Germany.
4 secondary outcomes
Anthropometric measures
Time frame: 2 months
Assessment of participation age to sport
Time frame: 2 months
Assessment of number of hours of training per week
Time frame: 2 months
Assessment of training experience
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa A Osman, Assis. Prof. principal investigator
Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Anemia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hemoglobin (Hb) (time frame: 2 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.