NCT02263586

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,089

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

October 4, 2014

Last Update Submit

May 2, 2015

Conditions

Hyponatremia

Keywords

IronmanTriathlon

Outcome Measures

Primary Outcomes (1)

  • Electrolyte balance Blood sodium

    within 20 minutes after finishing the race

Secondary Outcomes (1)

  • Acid balance

    within 20 minutes after finishing the race

Interventions

Education in nutritionBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants of a long-distance triathlon

You may qualify if:

  • finisher of a long-distance triathlon
  • \> 18 years
  • \< 60 years

You may not qualify if:

  • not finished a long-distance triathlon
  • \< 18 years
  • \> 60 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related 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. doi: 10.1056/NEJMoa043901.

    PMID: 15829535RESULT

MeSH Terms

Conditions

Hyponatremia

Interventions

Educational StatusNutritional Status

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemography

Study Officials

  • Stefan Braunecker, M.D.

    University Hospital Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Researcher

Study Record Dates

First Submitted

October 4, 2014

First Posted

October 13, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

DE(1)