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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Western States Endurance Run Research Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Western States Endurance Run Research Foundation
ClinicalTrials.gov Identifier:
NCT01110655
First received: April 23, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Exercise-associated Hyponatremia
 Other: Intravenous hypertonic Saline
Other: Oral hypertonic saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Western States Endurance Run Research Foundation:

Primary Outcome Measures:
  • Blood sodium concentration post administration of oral or IV hypertonic saline. [ Time Frame: 1 hour post administration of hypertonic saline ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous hypertonic saline Other: Intravenous hypertonic Saline
Intravenous 100mL bolus of 3% saline
Experimental: Oral hypertonic saline Other: Oral hypertonic saline
Oral 100mL bolus of 3% saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • consenting Western States 100 race finisher
  • hyponatremic

Exclusion Criteria:

  • altered mental status
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110655

Contacts
Contact: Martin D Hoffman, MD (916) 843-9027 martin.hoffman@va.gov
Contact: Bethan E Owen, BM bethanelin@yahoo.com

Locations
United States, California
Western States Endurance Run Recruiting
Sacramento, California, United States, 95835
Contact: Martin D Hofman, MD     916-843-9027     martin.hoffman@va.gov    
Contact: Bethan E Owen, BM         bethanelin@yahoo.com    
Principal Investigator: Tamara Hew-Butler, DPM, PhD            
Sponsors and Collaborators
Western States Endurance Run Research Foundation
Investigators
Study Chair: Martin D Hoffman, MD Western States Endurance Run Foundation
  More Information

No publications provided

Responsible Party: Martin D. Hoffman, MD, Western States Endurance Run
ClinicalTrials.gov Identifier: NCT01110655     History of Changes
Other Study ID Numbers: WSER 2009
Study First Received: April 23, 2010
Last Updated: April 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Western States Endurance Run Research Foundation:
Exercise-associated hyponatremia
Randomized treatment trial
Endurance runners

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013