NCT01110655

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 26, 2010

Status Verified

April 1, 2010

Enrollment Period

1 year

First QC Date

April 23, 2010

Last Update Submit

April 23, 2010

Conditions

Exercise-associated Hyponatremia

Keywords

Exercise-associated hyponatremiaRandomized treatment trialEndurance runners

Outcome Measures

Primary Outcomes (1)

  • Blood sodium concentration post administration of oral or IV hypertonic saline.

    1 hour post administration of hypertonic saline

Study Arms (2)

Intravenous hypertonic saline

EXPERIMENTAL
Other: Intravenous hypertonic Saline

Oral hypertonic saline

EXPERIMENTAL
Other: Oral hypertonic saline

Interventions

Intravenous hypertonic SalineOTHER

Intravenous 100mL bolus of 3% saline

Intravenous hypertonic saline
Oral hypertonic salineOTHER

Oral 100mL bolus of 3% saline

Oral hypertonic saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • consenting Western States 100 race finisher
  • hyponatremic

You may not qualify if:

  • altered mental status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western States Endurance Run

Sacramento, California, 95835, United States

RECRUITING

MeSH Terms

Interventions

Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Martin D Hoffman, MD

    Western States Endurance Run Foundation

    STUDY CHAIR

Central Study Contacts

Martin D Hoffman, MD

CONTACT

(916) 843-9027martin.hoffman@va.gov

Bethan E Owen, BM

CONTACT

bethanelin@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 26, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 26, 2010

Record last verified: 2010-04

Locations

US(1)