Iron Metabolism in Dragon Boat Athletes

This study has been completed.

Sponsor:

Collaborators:

MVZ für Laboratoriumsmedizin Koblenz

Deutscher Drachenboot Verband e.V.

Information provided by (Responsible Party):

Andree Hillebrecht, University of Giessen

ClinicalTrials.gov Identifier:

NCT01431118

First received: August 31, 2011

Last updated: July 21, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2011

Last Updated Date

July 21, 2012

Start Date ^ICMJE

April 2011

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change from Baseline in prohepcidin after performing dragonboating [ Time Frame: pre and post exercise intervention at the same day ] [ Designated as safety issue: No ]

one meassurement of prohepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day

Original Primary Outcome Measures ^ICMJE

change from Baseline in prohepcidin after performing dragonboating [ Time Frame: pre and post exercise ] [ Designated as safety issue: No ]

meassurement of prohepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day

Change History

Complete list of historical versions of study NCT01431118 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

haematocrit [ Time Frame: pre and post exercise intervention at the same day ] [ Designated as safety issue: No ]
one meassurement of haematocrit immediate before and within three hours after performing two to four specific dragonboat intervention at the same day
value of reticulocytes [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
one meassurement of reticulocytes immediate before performing two to four specific dragonboat interventions
value of hypochromic erythrocytes [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
one meassurement of hypochromic erythrocytes immediate before performing two to four specific dragonboat interventions
change from Baseline in serum iron after performing dragonboating [ Time Frame: pre and post exercise intervention at the same day ] [ Designated as safety issue: No ]
one meassurement of serum iron immediate before and within three hours after performing two to four specific dragonboat interventions at the same day
value of transferrin [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
one meassurement of transferrin immediate before performing two to four specific dragonboat interventions
value of transferrin saturation [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
one meassurement of transferrin saturation immediate before performing two to four specific dragonboat interventions
value of ferritin [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
one meassurement of ferritin immediate before performing two to four specific dragonboat interventions
change from Baseline in hepcidin after performing dragonboating [ Time Frame: pre and post exercise intervention at the same day ] [ Designated as safety issue: No ]
one meassurement of hepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day

Original Secondary Outcome Measures ^ICMJE

haematocrit [ Time Frame: pre and post exercise ] [ Designated as safety issue: No ]
meassurement of haematocrit immediate before and within three hours after performing two to four specific dragonboat intervention at the same day
value of reticulocytes [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
meassurement of reticulocytes immediate before performing two to four specific dragonboat interventions
value of hypochromic erythrocytes [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
meassurement of hypochromic erythrocytes immediate before performing two to four specific dragonboat interventions
change from Baseline in serum iron after performing dragonboating [ Time Frame: pre and post exercise ] [ Designated as safety issue: No ]
meassurement of serum iron immediate before and within three hours after performing two to four specific dragonboat interventions at the same day
value of transferrin [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
meassurement of transferrin immediate before performing two to four specific dragonboat interventions
value of transferrin saturation [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
meassurement of transferrin saturation immediate before performing two to four specific dragonboat interventions
value of ferritin [ Time Frame: pre exercise ] [ Designated as safety issue: No ]
meassurement of ferritin immediate before performing two to four specific dragonboat interventions
change from Baseline in hepcidin after performing dragonboating [ Time Frame: pre and post exercise ] [ Designated as safety issue: No ]
meassurement of hepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Iron Metabolism in Dragon Boat Athletes

Official Title ^ICMJE

Iron Metabolism in Dragon Boat Athletes - An Analysis of Changes in Blood Count Parameters Under Sport-specific Stress

Brief 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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Anaemia

Intervention ^ICMJE

Other: specific dragon boating training intervention
male athletes of the german national dragon boat team performing three specific training units at one day
Other: specific dragon boat intervention
women athletes of the german national dragon boat team performing two specific training units and one weight lifting test at one day

Study Arm (s)

Active Comparator: sports intervention male
male athletes of the german national dragon boat team

Intervention: Other: specific dragon boating training intervention
Active Comparator: sports intervention women
women athletes of the german national dragon boat team

Intervention: Other: specific dragon boat intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

athletes performing dragon boat sport

Exclusion Criteria:

acute clinically significant intercurrent diseases

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01431118

Other Study ID Numbers ^ICMJE

Gi-02-2011

Has Data Monitoring Committee

Responsible Party

Andree Hillebrecht, University of Giessen

Study Sponsor ^ICMJE

University of Giessen

Collaborators ^ICMJE

MVZ für Laboratoriumsmedizin Koblenz
Deutscher Drachenboot Verband e.V.

Investigators ^ICMJE

Principal Investigator:

Andree Hillebrecht, Dr. med.

Department of sportsmedicine- University Giessen

Information Provided By

University of Giessen

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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