Iron DeficiencyFERDOPNCT03014921
Impact of Iron Injection on Blood Donation
A study testing iron injection and saline solution injection in people with Iron Deficiency, run by Nicolas Leuenberger.
Trial summary
This trial study and compare in blood and urinary matrices the impact of an iron injection on proteins involved in iron metabolism during a blood donation. The goal is to study the impact of an iron injection on detection markers of a blood donation in the anti-doping field Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- iron injection and saline solution injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Apr 2017
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 20 and 35 yo
- BMI between 18 and 30
- Ferritin < 50ug/l
- Transferrin saturation < 20 if ferritin between 20 and 50ug/l
Who cannot join
- high level athlete
- blood donation within 6 months before the study
- liver disorder
About this study
Official title: Effet de l'Injection de Fer Sur la Donation Sanguine, étude randomisée et contrôlée
This trial study and compare in blood and urinary matrices the impact of an iron injection on proteins involved in iron metabolism during a blood donation. The goal is to study the impact of an iron injection on detection markers of a blood donation in the anti-doping field
Read the detailed description
This study aim to investigate the impact of an iron injection on the proteins involved in iron metabolism during blood donation and to compare the blood and urinary matrix. A messenger RNA profiling will be performed as well. The goal is to investigate the impact of iron injection on the markers of blood donation detection in the anti-doping field.
The study will take place over a period of 8 weeks.
Volunteers will be randomly assigned to two groups. Randomization will be provided by a software made for this purpose. An injection of 500 mg of iron in 250mL of saline solution or a placebo injection containing only the saline solution will be performed. Standard blood sampling (in the arm) and finger prick blood sampling will be carried out. After that, 500 mL blood donation will be done. Standard blood sampling and finger prick blood sampling will be performed before and after the donation.
The study will be done in "simple blind", meaning that volunteers will not know if they get iron or saline solution.
On the days of iron or saline solution injection and blood donation, blood sampling will be done up to 12 hours after the injection. After that, blood sampling will be scheduled up to 30 days after blood donation at a rate of once a day (except for the weekends).
- Conditions
- Iron Deficiency
- Being tested
- iron injection, saline solution injection
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron injectionOther
Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
saline solution injectionOther
Injection of a 250mL saline solution
| Study group | Role | What they receive |
|---|---|---|
| placebo injection group | Placebo comparator | saline solution injection as placebo Receives: Other: saline solution injection |
| iron injection group | Active comparator | iron injection Receives: Other: iron injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin level variations due to iron injection or blood donation
measurements will be done in ug/l
Measured: 8 weeks
Secondary outcomes (2)
Hemoglobin level variations due to iron injection or blood donation
measurements will be done in g/dL
Measured: 8 weeks
Reticulocyte% variations due to iron injection or blood donation
measurements will be done in %
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolas Leuenberger
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor-investigator, Nicolas Leuenberger, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014921
- Sponsor's protocol ID
- 2016-00324
- Other IDs
- 2016
- Acronym
- FERDOP
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2016
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effet de l'Injection de Fer Sur la Donation Sanguine, étude randomisée et contrôlée
- ClinicalTrials.gov ID
- NCT03014921
- Acronym / sponsor ID
- FERDOP / 2016-00324
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nicolas LeuenbergerUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- 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 trial study and compare in blood and urinary matrices the impact of an iron injection on proteins involved in iron metabolism during a blood donation. The goal is to study the impact of an iron injection on detection markers of a blood donation in the anti-doping field
Detailed description
This study aim to investigate the impact of an iron injection on the proteins involved in iron metabolism during blood donation and to compare the blood and urinary matrix. A messenger RNA profiling will be performed as well. The goal is to investigate the impact of iron injection on the markers of blood donation detection in the anti-doping field.
The study will take place over a period of 8 weeks.
Volunteers will be randomly assigned to two groups. Randomization will be provided by a software made for this purpose. An injection of 500 mg of iron in 250mL of saline solution or a placebo injection containing only the saline solution will be performed. Standard blood sampling (in the arm) and finger prick blood sampling will be carried out. After that, 500 mL blood donation will be done. Standard blood sampling and finger prick blood sampling will be performed before and after the donation.
The study will be done in "simple blind", meaning that volunteers will not know if they get iron or saline solution.
On the days of iron or saline solution injection and blood donation, blood sampling will be done up to 12 hours after the injection. After that, blood sampling will be scheduled up to 30 days after blood donation at a rate of once a day (except for the weekends).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo injection group | Placebo comparator | Other: saline solution injectionsaline solution injection as placebo |
| iron injection group | Active comparator | Other: iron injectioniron injection |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male between 20 and 35 yo
- BMI between 18 and 30
- Ferritin < 50ug/l
- Transferrin saturation < 20 if ferritin between 20 and 50ug/l
Key exclusion criteria (3 listed)
- high level athlete
- blood donation within 6 months before the study
- liver disorder
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 |
|---|---|---|
| iron injectionInjection of a 250mL saline solution added with 500mg of iron (Ferinject) | Other | iron injection group |
| saline solution injectionInjection of a 250mL saline solution | Other | placebo injection group |
Primary outcome
Serum ferritin level variations due to iron injection or blood donation
Time frame: 8 weeks
measurements will be done in ug/l
2 secondary outcomes
Hemoglobin level variations due to iron injection or blood donation
Time frame: 8 weeks
Reticulocyte% variations due to iron injection or blood donation
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Individual participant dataSharing planned: No
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Iron Deficiencies
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.
Questions about this trial
What is this clinical trial studying?
A study testing iron injection and saline solution injection in people with Iron Deficiency, run by Nicolas Leuenberger.
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: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Serum ferritin level variations due to iron injection or blood donation (time frame: 8 weeks). 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 9 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.