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

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ClinicalTrials.gov Identifier: NCT01110655
Recruitment Status : Unknown
Verified April 2010 by Western States Endurance Run Research Foundation.
Recruitment status was:  Recruiting
First Posted : April 26, 2010
Last Update Posted : April 26, 2010
Sponsor:
Information provided by:
Western States Endurance Run Research Foundation

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.

Condition or disease Intervention/treatment
Exercise-associated Hyponatremia Other: Intravenous hypertonic Saline Other: Oral hypertonic saline

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • consenting Western States 100 race finisher
  • hyponatremic

Exclusion Criteria:

  • altered mental status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Martin D. Hoffman, MD, Western States Endurance Run
ClinicalTrials.gov Identifier: NCT01110655     History of Changes
Other Study ID Numbers: WSER 2009
First Posted: April 26, 2010    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: April 2010

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