Recruiting

Hypertonic Saline

Sponsor:

Western States Endurance Run Research Foundation

Code:

NCT01110655

Conditions

Exercise-associated Hyponatremia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intravenous hypertonic Saline

Oral hypertonic saline

Study Details

Brief summary:

The purpose of the study is to 1) evaluate incidence and primary cause of exercise-associated Hyponatremia (EAH) in race finishers participating in the Western States 100-mile Endurance Run, 2) determine if the ingestion of oral hypertonic saline (high salt) is as effective as intravenous administration of hypertonic saline to elevate below-normal blood salt concentrations (EAH) at the end of the Western States Endurance Run, and 3) determine if oral and intravenous hypertonic saline solutions are equally as effective at reversing mild (without altered mental status) symptoms associated with EAH.

Conditions

Exercise-associated Hyponatremia

Study ID

NCT01110655

Start date

Jun, 2009

Status verified date

Apr, 2010

Completion date

Jun, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • consenting Western States 100 race finisher
  • hyponatremic

Exclusion Criteria:

  • altered mental status

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intravenous hypertonic saline

experimental: Oral hypertonic saline

Interventions

Intravenous hypertonic Saline

Intravenous 100mL bolus of 3% saline

Oral hypertonic saline

Oral 100mL bolus of 3% saline

Primary outcome measure

  • Blood sodium concentration post administration of oral or IV hypertonic saline. [ Time Frame: 1 hour post administration of hypertonic saline ]

Central Contacts and Locations

Central contacts

Locations

Western States Endurance Run

Recruiting

Sacramento, California, United States, 95835

Contacts

Bethan E Owen, BM

bethanelin@yahoo.com

Principal Investigator:

Tamara Hew-Butler, DPM, PhD

More Information

Sponsor

Western States Endurance Run Research Foundation

Last update posted

Apr 26, 2010

Last verified

Apr, 2010

Keywords

  • Exercise-associated hyponatremia
  • Randomized treatment trial
  • Endurance runners

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western States Endurance Run Research Foundation on 2010-04-26.