Influence of Triathlon on the Electrolyte Balance | NCT02263586

Studies
Influence of Triathlon on the Electrolyte Balance

NCT02263586

Sponsor

University Hospital of Cologne

Status

Completed

Last Update Posted

May 5, 2015Estimated

Enrollment

1,089Actual

Phase

Not provided

Conditions

Hyponatremia

Interventions

Education in nutrition

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Apr 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Oct 4, 2014

First Submission Date that Met QC Criteria

Oct 8, 2014

First Posted Date

Oct 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2015

Last Update Posted Date

May 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Stefan Braunecker, Anesthesiologist, Researcher, University Hospital of ColognePrincipal Investigator

Lead Sponsor

University Hospital of CologneOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,089Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education in nutrition	Behavioral	Athletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electrolyte balance Blood sodium		within 20 minutes after finishing the race

Secondary Outcomes

Measure	Description	Time Frame
Acid balance		within 20 minutes after finishing the race

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Participants of a long-distance triathlon

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Braunecker, M.D.	University Hospital Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uniklinik Köln		Cologne	North Rhine-Westphalia	50937	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15829535	Result	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.

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004522	Educational Status
D009752	Nutritional Status

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition