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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02263586
Other study ID # Ironman
Secondary ID
Status Completed
Phase N/A
First received October 4, 2014
Last updated May 2, 2015
Start date August 2014
Est. completion date May 2015

Study information

Verified date May 2015
Source University Hospital of Cologne
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Aim of the study is examining the incidence of the occurrence of hyponatremia during a Triathlon


Description:

Studies in similar endurance sports (e.g. marathon) could already indicate a high incidence for the appearance of hyponatremia during competitions. The loss of sodium through sweating and the excessive fluid intake during the competitions is a primary risk factor for the development of hyponatremia.

Based on the known occurrence of hyponatremia in marathon runners, participants of the Ironman European Championship between the years 2005 and 2014 were screened for the occurrence of hyponatremia after finishing the race for safety reasons. Subjects were approached at random in the athlete's garden and invited to participate. All participants were 18 years or older.


Recruitment information / eligibility

Status Completed
Enrollment 1089
Est. completion date May 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- finisher of a long-distance triathlon

- > 18 years

- < 60 years

Exclusion Criteria:

- not finished a long-distance triathlon

- < 18 years

- > 60 years

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Education in nutrition
Athletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon.

Locations

Country Name City State
Germany Uniklinik Köln Köln NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Almond CS, Shin AY, Fortescue EB, Mannix RC, Wypij D, Binstadt BA, Duncan CN, Olson DP, Salerno AE, Newburger JW, Greenes DS. Hyponatremia among runners in the Boston Marathon. N Engl J Med. 2005 Apr 14;352(15):1550-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Electrolyte balance Blood sodium within 20 minutes after finishing the race Yes
Secondary Acid balance within 20 minutes after finishing the race Yes
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