InflammationNCT06878040
Effect of Baseline Ferritin Level on Iron Status in Male Elite Youth Rowers
An observational study of Inflammation and Iron Deficiency Anemias, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The data of 16 trained men from the Polish Youth National Rowing. All athletes presented as medically fit, with no underlying health problems. In this cohort, baseline serum ferritin levels were considered, and the athletes were divided into two groups: 1. Serum ferritin <75 ng/ml (SF<75): n=9 2. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men only
- Conditions the study is for
- Inflammation, Iron Deficiency Anemias, Red Blood Cell
- How many people
- 16 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2023to 10 Jun 2023
- 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 18 to 24 years
- Men only
- No healthy volunteers
- Adult
Study population: Youth National Rowing Team of Poland
Who may be able to join
- Training experience a minimum of five years
- Minimum training time per week 240 minute
- Membership in the Youth National Rowing Team of Poland
- Completion of the 2000m ergometer test on two test dates
Who cannot join
- Taking other supplements containing anthocyanin compounds during the study period or a month earlier
- Antibiotic therapy
- Health problems
Trial locations and contacts
1 site in 1 country.
About this study
The data of 16 trained men from the Polish Youth National Rowing. All athletes presented as medically fit, with no underlying health problems. In this cohort, baseline serum ferritin levels were considered, and the athletes were divided into two groups:
- Serum ferritin <75 ng/ml (SF<75): n=9
- Serum ferritin >75 ng/ml (SF>75): n=7
Read more
The rowing test was performed at the beginning of the preparatory phase of the annual training cycle (April), which is characterized by high volume and training load. After a 5-min of individual warm-up, the athletes performed a 2000-m exercise test on a rowing ergometer (Concept II, USA). Blood samples took from the cubital vein at three time points: before stress test (pre-exercise), one minute after the end of the test (post-exercise), and after a 1-hour recovery period (1h recovery).
Measurements ferritin, transferrin, hepcidin and interleukin-6 (IL-6) levels were determined using ELISA kits (SunRed Biotechnology Company). The iron levels were determined on the SPECTROstar Nano reader.
Read the detailed description
The data of 16 trained men from the Polish Youth National Rowing. All athletes presented as medically fit, with no underlying health problems. In this cohort, baseline serum ferritin levels were considered, and the athletes were divided into two groups:
- Serum ferritin <75 ng/ml (SF<75): n=9
- Serum ferritin >75 ng/ml (SF>75): n=7
The rowing test was performed at the beginning of the preparatory phase of the annual training cycle (April), which is characterized by high volume and training load. After a 5-min of individual warm-up, the athletes performed a 2000-m exercise test on a rowing ergometer (Concept II, USA). Blood samples took from the cubital vein at three time points: before stress test (pre-exercise), one minute after the end of the test (post-exercise), and after a 1-hour recovery period (1h recovery).
Measurement: All determined parameters will be measured with the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and using commercial assay kits. Measurements will be performed by the project contractors.
- Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant will be used for the following tests: (a) complete blood count (7 parameters) determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland). Red blood cell indices: RBC (Red Blood Cells), HGB (Hemoglobin), HCT (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Blood cells Distribution Width).
- Polyethylene clotting activator tubes (9 ml) will be centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum will be pipetted into several Eppendorf tubes, which will then be frozen (temp. -80 °C). All the following biochemical parameters will be determined from the extracted serum:
- using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:
- iron status parameters: hepcidin, transferrin , ferritin,
- indicators of inflammation: IL-6.
- The iron levels be determined using the colorimetric method on the SPECTROstar Nano reader.
- The lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Dr. Lange, Germany).
Youth National Rowing Team of Poland The athletes' diets were completely analyzed before each exercise test by a nutritionist. Participants, with the help of a dietician who was available during meals on test days, filled out food diaries. The amount of energy, protein, carbohydrates, fats and fiber were then analyzed using a commercially available program.
The experiment was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of the Medical University of Poznan (decision no. 685/23 in 2023).
- Conditions
- Inflammation, Iron Deficiency Anemias, Red Blood Cell
- Medical subject headings
- Inflammation, Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin
Concentration of ferritin [ng/mL]. ELISA method by the test manufacturer's instructions
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Iron
The iron level [µg/dL] will be determined using the colorimetric method on the SPECTROstar Nano reader.
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Interleukin-6 (Il-6)
Concentration of IL-6 [ng/L]. ELISA method by the test manufacturer's instructions
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Hepcidin
Concentration of hepcidin [ng/mL]. ELISA method by the test manufacturer's instructions
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Transferrin
Concentration of transferrin [mg/mL]. ELISA method by the test manufacturer's instructions
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The Blood morphology - RBC (Red Blood Cells)
RBC (Red Blood Cells) [106 × µL-1] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The Blood morphology- HGB (Hemoglobin)
HGB (Hemoglobin) [g/dL] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The Blood morphology- HCT (Hematocrit)
HCT (Hematocrit) [%]determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The Blood morphology- MCV (Mean Corpuscular Volume)
MCV (Mean Corpuscular Volume)[fl] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The Blood morphology- MCH (Mean Corpuscular Hemoglobin)
MCH (Mean Corpuscular Hemoglobin) [pg] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The Blood morphology- MCHC (Mean Corpuscular Hemoglobin Concentration)
MCHC (Mean Corpuscular Hemoglobin Concentration) [g x dL-1] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The Blood morphology- RDW (Red Blood cells Distribution Width)
RDW (Red Blood cells Distribution Width) [%] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
Measured: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Secondary outcomes (7)
Antropometric characteristic - height
Prior to the exercise test, the investigators measured the anthropometric parameters, including height (Seca 213 Hamburg, Deutschland) [cm]
Measured: Day 1 after overall fast
Antropometric characteristic - weight
Prior to the exercise test, the investigators measured the anthropometric parameters, including weight (Tanita BC 418 MA, Tanita Corporation, Tokyo, Japan) [kg]
Measured: Day 1 after overall fast
Food record - energy
Participants will prepare a food record. The results will be calculated using the dietetykpro program: energy [kcal]
Measured: Day before the Day 1, in the morning at Day 1
Food record - protein
Participants will prepare a food record. The results will be calculated using the dietetykpro program: protein [g]
Measured: Day before the Day 1, in the morning at Day 1
Food record - carobhydrates
Participants will prepare a food record. The results will be calculated using the dietetykpro program: carbohydrates [g]
Measured: Day before the Day 1, in the morning at Day 1
Food record - fiber
Participants will prepare a food record. The results will be calculated using the dietetykpro program: fiber [g]
Measured: Day before the Day 1, in the morning at Day 1
Food record - fat
Participants will prepare a food record. The results will be calculated using the dietetykpro program: fat [g]
Measured: Day before the Day 1, in the morning at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Apr 2023
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878040
- Sponsor's protocol ID
- WIOSŁA2023
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baseline Ferritin Level on Iron Status in Male Elite Youth Rowers
- ClinicalTrials.gov ID
- NCT06878040
- Acronym / sponsor ID
- WIOSŁA2023
- Conditions
- Inflammation, Iron Deficiency Anemias, Red Blood Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 14 Mar 2025 (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.
The data of 16 trained men from the Polish Youth National Rowing. All athletes presented as medically fit, with no underlying health problems. In this cohort, baseline serum ferritin levels were considered, and the athletes were divided into two groups:
- Serum ferritin <75 ng/ml (SF<75): n=9
- Serum ferritin >75 ng/ml (SF>75): n=7
The rowing test was performed at the beginning of the preparatory phase of the annual training cycle (April), which is characterized by high volume and training load. After a 5-min of individual warm-up, the athletes performed a 2000-m exercise test on a rowing ergometer (Concept II, USA). Blood samples took from the cubital vein at three time points: before stress test (pre-exercise), one minute after the end of the test (post-exercise), and after a 1-hour recovery period (1h recovery).
Measurements ferritin, transferrin, hepcidin and interleukin-6 (IL-6) levels were determined using ELISA kits (SunRed Biotechnology Company). The iron levels were determined on the SPECTROstar Nano reader.
Detailed description
The data of 16 trained men from the Polish Youth National Rowing. All athletes presented as medically fit, with no underlying health problems. In this cohort, baseline serum ferritin levels were considered, and the athletes were divided into two groups:
- Serum ferritin <75 ng/ml (SF<75): n=9
- Serum ferritin >75 ng/ml (SF>75): n=7
The rowing test was performed at the beginning of the preparatory phase of the annual training cycle (April), which is characterized by high volume and training load. After a 5-min of individual warm-up, the athletes performed a 2000-m exercise test on a rowing ergometer (Concept II, USA). Blood samples took from the cubital vein at three time points: before stress test (pre-exercise), one minute after the end of the test (post-exercise), and after a 1-hour recovery period (1h recovery).
Measurement: All determined parameters will be measured with the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and using commercial assay kits. Measurements will be performed by the project contractors.
- Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant will be used for the following tests: (a) complete blood count (7 parameters) determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland). Red blood cell indices: RBC (Red Blood Cells), HGB (Hemoglobin), HCT (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Blood cells Distribution Width).
- Polyethylene clotting activator tubes (9 ml) will be centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum will be pipetted into several Eppendorf tubes, which will then be frozen (temp. -80 °C). All the following biochemical parameters will be determined from the extracted serum:
- using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:
- iron status parameters: hepcidin, transferrin , ferritin,
- indicators of inflammation: IL-6.
- The iron levels be determined using the colorimetric method on the SPECTROstar Nano reader.
- The lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Dr. Lange, Germany).
Youth National Rowing Team of Poland The athletes' diets were completely analyzed before each exercise test by a nutritionist. Participants, with the help of a dietician who was available during meals on test days, filled out food diaries. The amount of energy, protein, carbohydrates, fats and fiber were then analyzed using a commercially available program.
The experiment was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of the Medical University of Poznan (decision no. 685/23 in 2023).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Youth National Rowing Team of Poland
Key inclusion criteria (4 listed)
- Training experience a minimum of five years
- Minimum training time per week 240 minute
- Membership in the Youth National Rowing Team of Poland
- Completion of the 2000m ergometer test on two test dates
Key exclusion criteria (3 listed)
- Taking other supplements containing anthocyanin compounds during the study period or a month earlier
- Antibiotic therapy
- Health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ferritin
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Concentration of ferritin [ng/mL]. ELISA method by the test manufacturer's instructions
Iron
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
The iron level [µg/dL] will be determined using the colorimetric method on the SPECTROstar Nano reader.
Interleukin-6 (Il-6)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Concentration of IL-6 [ng/L]. ELISA method by the test manufacturer's instructions
Hepcidin
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Concentration of hepcidin [ng/mL]. ELISA method by the test manufacturer's instructions
Transferrin
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
Concentration of transferrin [mg/mL]. ELISA method by the test manufacturer's instructions
The Blood morphology - RBC (Red Blood Cells)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
RBC (Red Blood Cells) [106 × µL-1] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
The Blood morphology- HGB (Hemoglobin)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
HGB (Hemoglobin) [g/dL] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
The Blood morphology- HCT (Hematocrit)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
HCT (Hematocrit) [%]determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
The Blood morphology- MCV (Mean Corpuscular Volume)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
MCV (Mean Corpuscular Volume)[fl] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
The Blood morphology- MCH (Mean Corpuscular Hemoglobin)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
MCH (Mean Corpuscular Hemoglobin) [pg] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
The Blood morphology- MCHC (Mean Corpuscular Hemoglobin Concentration)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
MCHC (Mean Corpuscular Hemoglobin Concentration) [g x dL-1] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
The Blood morphology- RDW (Red Blood cells Distribution Width)
Time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.
RDW (Red Blood cells Distribution Width) [%] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).
7 secondary outcomes
Antropometric characteristic - height
Time frame: Day 1 after overall fast
Antropometric characteristic - weight
Time frame: Day 1 after overall fast
Food record - energy
Time frame: Day before the Day 1, in the morning at Day 1
Food record - protein
Time frame: Day before the Day 1, in the morning at Day 1
Food record - carobhydrates
Time frame: Day before the Day 1, in the morning at Day 1
Food record - fiber
Time frame: Day before the Day 1, in the morning at Day 1
Food record - fat
Time frame: Day before the Day 1, in the morning at Day 1
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 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammation and Iron Deficiency Anemias, run by Poznan University of Physical Education at 1 site in Poland.
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 4 inclusion and 3 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 20 Mar 2025. 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 Poland. 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?
Ferritin (time frame: At rest (before the test), directly after the test, and after a 1-hour recovery period.). The study lists 12 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 20 Mar 2025.