NCT01431118

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

August 31, 2011

Last Update Submit

July 21, 2012

Conditions

Anaemia

Keywords

iron metabolismhepcidindragon boatingsport-specific stressironanaemiasport

Outcome Measures

Primary Outcomes (1)

  • 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

    pre and post exercise intervention at the same day

Secondary Outcomes (8)

  • haematocrit

    pre and post exercise intervention at the same day

  • value of reticulocytes

    pre exercise

  • value of hypochromic erythrocytes

    pre exercise

  • change from Baseline in serum iron after performing dragonboating

    pre and post exercise intervention at the same day

  • value of transferrin

    pre exercise

  • +3 more secondary outcomes

Study Arms (2)

sports intervention male

ACTIVE COMPARATOR

male athletes of the german national dragon boat team

Other: specific dragon boating training intervention

sports intervention women

ACTIVE COMPARATOR

women athletes of the german national dragon boat team

Other: specific dragon boat intervention

Interventions

specific dragon boating training interventionOTHER

male athletes of the german national dragon boat team performing three specific training units at one day

sports intervention male
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

sports intervention women

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • athletes performing dragon boat sport

You may not qualify if:

  • acute clinically significant intercurrent diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Andree Hillebrecht, Dr. med.

    Department of sportsmedicine- University Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med.

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 9, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 24, 2012

Record last verified: 2012-07