Sports Drug AbuseNCT04965961
The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females
A study testing EPO in people with Sports Drug Abuse, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Sports Drug Abuse
- What is being tested?
- EPO
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Aug 2019to Jan 2024
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants
Who cannot join
- Age
- Insufficient fitness level
- Blood donation 3 months prior to enrollment
- Altitude exposure 2 months before enrollment
- Hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.
Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.
Read the detailed description
In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.
- Conditions
- Sports Drug Abuse
- Being tested
- EPO, Control group - saline injection
- Keywords
- erythropoeitin, doping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPODrug
Please refer to the arm description
Control group - saline injectionOther
Please refer to the arm description
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human erythropoietin treatment | Experimental | Participants receive intravenous injections of 9 International Units per kg bodyweight epoetin-β (NeoRecormon, Roche, Mannheim, Germany) three times per week for four weeks on non-consecutive days. Subjects receive tablets with 80mg iron (Tardyferon, Pierre Fabre Pharme GmbH, Freiburg, Germany) to ensure sufficient iron stores for the expected increase in erythropoeisis. Receives: Drug: EPO |
| Control group | Placebo comparator | Participants receive intravenous injections of ~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days. Receives: Other: Control group - saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal oxygen uptake
Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.
Measured: Change from baseline to 5 days after last injection
Change in time trial performance
Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial.
Measured: Change from baseline to 3 days after last injection
Change in total hemoglobin mass
Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.
Measured: Change from baseline to 3 days after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start28 Aug 2019
- Primary completion17 May 2021
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sports Drug AbuseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Explorative
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolai Nordsborg, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965961
- Sponsor's protocol ID
- H-18013069
- Status last verified
- Nov 2023
- First submitted
- 28 Jun 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Fully anonymous data can be shared with other researchers.
Publications
Breenfeldt Andersen A, Bejder J, Bonne TC, Graae J, Seier S, Nordsborg NB. Changes in Immature Reticulocytes Aid the Indirect Detection of Microdose Recombinant Erythropoietin Use in Men and Women. Med Sci Sports Exerc. 2023 Sep 1;55(9):1695-1705. doi: 10.1249/MSS.0000000000003197. Epub 2023 Apr 24.
PubMed 37095637Breenfeldt Andersen A, Graae J, Bejder J, Bonne TC, Seier S, Debertin M, Eibye K, Hostrup M, Nordsborg NB. Microdoses of Recombinant Human Erythropoietin Enhance Time Trial Performance in Trained Males and Females. Med Sci Sports Exerc. 2023 Feb 1;55(2):311-321. doi: 10.1249/MSS.0000000000003052. Epub 2022 Nov 1.
PubMed 36317927
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.
- ClinicalTrials.gov ID
- NCT04965961
- Acronym / sponsor ID
- H-18013069
- Conditions
- Sports Drug Abuse
- Keywords
- erythropoeitin, doping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- Jan 2024 (estimated)
- First posted
- 16 Jul 2021 (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.
Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.
Detailed description
In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Explorative
| Arm | Type | Receives |
|---|---|---|
| Recombinant human erythropoietin treatment | Experimental | Drug: EPOParticipants receive intravenous injections of 9 International Units per kg bodyweight epoetin-β (NeoRecormon, Roche, Mannheim, Germany) three times per week for four weeks on non-consecutive days. Subjects receive tablets with 80mg iron (Tardyferon, Pierre Fabre Pharme GmbH, Freiburg, Germany) to ensure sufficient iron stores for the expected increase in erythropoeisis. |
| Control group | Placebo comparator | Other: Control group - saline injectionParticipants receive intravenous injections of ~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants
Key exclusion criteria (5 listed)
- Age
- Insufficient fitness level
- Blood donation 3 months prior to enrollment
- Altitude exposure 2 months before enrollment
- Hypertension
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 |
|---|---|---|
| EPOPlease refer to the arm description | Drug | Recombinant human erythropoietin treatment |
| Control group - saline injectionPlease refer to the arm description | Other | Control group |
Primary outcome
Change in maximal oxygen uptake
Time frame: Change from baseline to 5 days after last injection
Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.
Change in time trial performance
Time frame: Change from baseline to 3 days after last injection
Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial.
Change in total hemoglobin mass
Time frame: Change from baseline to 3 days after last injection
Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 37095637Breenfeldt Andersen A, Bejder J, Bonne TC, Graae J, Seier S, Nordsborg NB. Changes in Immature Reticulocytes Aid the Indirect Detection of Microdose Recombinant Erythropoietin Use in Men and Women. Med Sci Sports Exerc. 2023 Sep 1;55(9):1695-1705. doi: 10.1249/MSS.0000000000003197. Epub 2023 Apr 24.
- Derived from this study: PubMed 36317927Breenfeldt Andersen A, Graae J, Bejder J, Bonne TC, Seier S, Debertin M, Eibye K, Hostrup M, Nordsborg NB. Microdoses of Recombinant Human Erythropoietin Enhance Time Trial Performance in Trained Males and Females. Med Sci Sports Exerc. 2023 Feb 1;55(2):311-321. doi: 10.1249/MSS.0000000000003052. Epub 2022 Nov 1.
- Individual participant dataSharing planned: Undecided. Fully anonymous data can be shared with other researchers.
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?
A study testing EPO in people with Sports Drug Abuse, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Nov 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in maximal oxygen uptake (time frame: Change from baseline to 5 days after last injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965961, which also lists 2 linked publications.
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 29 Nov 2023.