AnaemiaNCT01431118
Iron Metabolism in Dragon Boat Athletes
A study testing specific dragon boating training intervention and specific dragon boat intervention in people with Anaemia, run by University of Giessen.
Trial summary
The purpose of the study is: To investigate the effect of sport-specific stress in the iron metabolism of dragon boat athletes To investigate the effects of sport-specific stress in the activity of pro-hepcidin and hepcidin Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anaemia
- What is being tested?
- specific dragon boating training intervention and specific dragon boat intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Apr 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- athletes performing dragon boat sport
Who cannot join
- acute clinically significant intercurrent diseases
About this study
Official title: Iron Metabolism in Dragon Boat Athletes - An Analysis of Changes in Blood Count Parameters Under Sport-specific Stress
The purpose of the study is:
- To investigate the effect of sport-specific stress in the iron metabolism of dragon boat athletes
- To investigate the effects of sport-specific stress in the activity of pro-hepcidin and hepcidin
Read the detailed description
This investigation evaluates the effects of sport-specific stress in iron metabolism of dragon boat athletes. Recent studies showed a significant increase in hepcidin activity under exercise (Röcker L. et al.(2005): Iron regulatory protein hepcidin is increased in female athletes after a marathon. European Journal of Applied Physiology, S. 95, 569-571)which possibly influences the iron metabolism.
In particular in this investigation the activity of pro-hepcidin and hepcidin under sport-specific stress is analysed. Therefore elite dragonboat athletes will be included to this study. Every athlete is tested once. At one exercise day from every athlete the iron metabolism especially the change of hepcidin, prohepcidin and iron before and after a specific dragonboat intervention is analysed.
- Conditions
- Anaemia
- Being tested
- specific dragon boating training intervention, specific dragon boat intervention
- Keywords
- iron metabolism, hepcidin, dragon boating, sport-specific stress, iron, anaemia, sport
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific dragon boating training interventionOther
male athletes of the german national dragon boat team performing three specific training units at one day
specific dragon boat interventionOther
women athletes of the german national dragon boat team performing two specific training units and one weight lifting test at one day
| Study group | Role | What they receive |
|---|---|---|
| sports intervention male | Active comparator | male athletes of the german national dragon boat team Receives: Other: specific dragon boating training intervention |
| sports intervention women | Active comparator | women athletes of the german national dragon boat team Receives: Other: specific dragon boat intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from Baseline in prohepcidin after performing dragonboating
one meassurement of prohepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day
Measured: pre and post exercise intervention at the same day
Secondary outcomes (8)
haematocrit
one meassurement of haematocrit immediate before and within three hours after performing two to four specific dragonboat intervention at the same day
Measured: pre and post exercise intervention at the same day
value of reticulocytes
one meassurement of reticulocytes immediate before performing two to four specific dragonboat interventions
Measured: pre exercise
value of hypochromic erythrocytes
one meassurement of hypochromic erythrocytes immediate before performing two to four specific dragonboat interventions
Measured: pre exercise
change from Baseline in serum iron after performing dragonboating
one meassurement of serum iron immediate before and within three hours after performing two to four specific dragonboat interventions at the same day
Measured: pre and post exercise intervention at the same day
value of transferrin
one meassurement of transferrin immediate before performing two to four specific dragonboat interventions
Measured: pre exercise
value of transferrin saturation
one meassurement of transferrin saturation immediate before performing two to four specific dragonboat interventions
Measured: pre exercise
value of ferritin
one meassurement of ferritin immediate before performing two to four specific dragonboat interventions
Measured: pre exercise
change from Baseline in hepcidin after performing dragonboating
one meassurement of hepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day
Measured: pre and post exercise intervention at the same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- MVZ für Laboratoriumsmedizin Koblenz, Deutscher Drachenboot Verband e.V.
- Responsible party
- Principal investigator, Andree Hillebrecht, University of Giessen
- Investigators
- Andree Hillebrecht, Dr. med., Principal investigator, Department of sportsmedicine- University Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431118
- Sponsor's protocol ID
- Gi-02-2011
- Status last verified
- Jul 2012
- First submitted
- 31 Aug 2011
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Metabolism in Dragon Boat Athletes - An Analysis of Changes in Blood Count Parameters Under Sport-specific Stress
- ClinicalTrials.gov ID
- NCT01431118
- Acronym / sponsor ID
- Gi-02-2011
- Conditions
- Anaemia
- Keywords
- iron metabolism, hepcidin, dragon boating, sport-specific stress, iron, anaemia, sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- MVZ für Laboratoriumsmedizin Koblenz, Deutscher Drachenboot Verband e.V.
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Sep 2011 (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.
The purpose of the study is:
- To investigate the effect of sport-specific stress in the iron metabolism of dragon boat athletes
- To investigate the effects of sport-specific stress in the activity of pro-hepcidin and hepcidin
Detailed description
This investigation evaluates the effects of sport-specific stress in iron metabolism of dragon boat athletes. Recent studies showed a significant increase in hepcidin activity under exercise (Röcker L. et al.(2005): Iron regulatory protein hepcidin is increased in female athletes after a marathon. European Journal of Applied Physiology, S. 95, 569-571)which possibly influences the iron metabolism.
In particular in this investigation the activity of pro-hepcidin and hepcidin under sport-specific stress is analysed. Therefore elite dragonboat athletes will be included to this study. Every athlete is tested once. At one exercise day from every athlete the iron metabolism especially the change of hepcidin, prohepcidin and iron before and after a specific dragonboat intervention is analysed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sports intervention male | Active comparator | Other: specific dragon boating training interventionmale athletes of the german national dragon boat team |
| sports intervention women | Active comparator | Other: specific dragon boat interventionwomen athletes of the german national dragon boat team |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- athletes performing dragon boat sport
Key exclusion criteria (1 listed)
- acute clinically significant intercurrent diseases
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 |
|---|---|---|
| specific dragon boating training interventionmale athletes of the german national dragon boat team performing three specific training units at one day | Other | sports intervention male |
| specific dragon boat interventionwomen athletes of the german national dragon boat team performing two specific training units and one weight lifting test at one day | Other | sports intervention women |
Primary outcome
change from Baseline in prohepcidin after performing dragonboating
Time frame: pre and post exercise intervention at the same day
one meassurement of prohepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day
8 secondary outcomes
haematocrit
Time frame: pre and post exercise intervention at the same day
value of reticulocytes
Time frame: pre exercise
value of hypochromic erythrocytes
Time frame: pre exercise
change from Baseline in serum iron after performing dragonboating
Time frame: pre and post exercise intervention at the same day
value of transferrin
Time frame: pre exercise
value of transferrin saturation
Time frame: pre exercise
value of ferritin
Time frame: pre exercise
change from Baseline in hepcidin after performing dragonboating
Time frame: pre and post exercise intervention at the same day
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 24 Jul 2012.
Related trials for Anaemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Andree Hillebrecht, Dr. med. principal investigator
Department of sportsmedicine- University Giessen
Questions about this trial
What is this clinical trial studying?
A study testing specific dragon boating training intervention and specific dragon boat intervention in people with Anaemia, run by University of Giessen.
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 1 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 24 Jul 2012. 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. 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?
change from Baseline in prohepcidin after performing dragonboating (time frame: pre and post exercise intervention at the same day). 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 24 Jul 2012.