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The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia

Incidence and Cause of Hyponatremia in Endurance Runners, Also to Determine if Oral Hypertonic Saline is as Efficacious as Intravenous Hypertonic Saline in the Correction of Below Normal Blood Sodium Concentrations in Runners With Hyponatremia Without Neurological Symptoms

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01110655
Enrollment
100
Registered
2010-04-26
Start date
2009-06-30
Completion date
2010-06-30
Last updated
2010-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise-associated Hyponatremia

Keywords

Exercise-associated hyponatremia, Randomized treatment trial, Endurance runners

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.

Interventions

Intravenous 100mL bolus of 3% saline

OTHEROral hypertonic saline

Oral 100mL bolus of 3% saline

Sponsors

Western States Endurance Run Research Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* consenting Western States 100 race finisher * hyponatremic

Exclusion criteria

* altered mental status

Design outcomes

Primary

MeasureTime frame
Blood sodium concentration post administration of oral or IV hypertonic saline.1 hour post administration of hypertonic saline

Countries

United States

Contacts

Primary ContactMartin D Hoffman, MD
martin.hoffman@va.gov(916) 843-9027
Backup ContactBethan E Owen, BM
bethanelin@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026