Exercise-associated HyponatremiaNCT01110655
The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia
A study testing Intravenous hypertonic Saline and Oral hypertonic saline in people with Exercise-associated Hyponatremia, run by Western States Endurance Run Research Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise-associated Hyponatremia
- What is being tested?
- Intravenous hypertonic Saline and Oral hypertonic saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consenting Western States 100 race finisher
- hyponatremic
Who cannot join
- altered mental status
Trial locations and contacts
1 site in 1 country.
Bethan E Owen, BM contact
United States1 site, 1 recruiting
- Recruiting
Western States Endurance Run
Sacramento, California, 95835
Martin D Hofman, MD, 916-843-9027, martin.hoffman@va.gov
Bethan E Owen, BM, bethanelin@yahoo.com
About this study
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
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
- Being tested
- Intravenous hypertonic Saline, Oral hypertonic saline
- Keywords
- Exercise-associated hyponatremia, Randomized treatment trial, Endurance runners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous hypertonic SalineOther
Intravenous 100mL bolus of 3% saline
Oral hypertonic salineOther
Oral 100mL bolus of 3% saline
| Study group | Role | What they receive |
|---|---|---|
| Intravenous hypertonic saline | Experimental | Not described Receives: Other: Intravenous hypertonic Saline |
| Oral hypertonic saline | Experimental | Not described Receives: Other: Oral hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sodium concentration post administration of oral or IV hypertonic saline.
Measured: 1 hour post administration of hypertonic saline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-associated HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western States Endurance Run Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Martin D Hoffman, MD, Study chair, Western States Endurance Run Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110655
- Sponsor's protocol ID
- WSER 2009
- Status last verified
- Apr 2010
- First submitted
- 23 Apr 2010
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01110655
- Acronym / sponsor ID
- WSER 2009
- Conditions
- Exercise-associated Hyponatremia
- Keywords
- Exercise-associated hyponatremia, Randomized treatment trial, Endurance runners
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western States Endurance Run Research FoundationUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous hypertonic saline | Experimental | Other: Intravenous hypertonic Saline |
| Oral hypertonic saline | Experimental | Other: Oral hypertonic saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- consenting Western States 100 race finisher
- hyponatremic
Key exclusion criteria (1 listed)
- altered mental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous hypertonic SalineIntravenous 100mL bolus of 3% saline | Other | Intravenous hypertonic saline |
| Oral hypertonic salineOral 100mL bolus of 3% saline | Other | Oral hypertonic saline |
Primary outcome
Blood sodium concentration post administration of oral or IV hypertonic saline.
Time frame: 1 hour post administration of hypertonic saline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethan E Owen, BM contact
Martin D Hoffman, MD study chair
Western States Endurance Run Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous hypertonic Saline and Oral hypertonic saline in people with Exercise-associated Hyponatremia, run by Western States Endurance Run Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin D Hoffman, MD ((916) 843-9027, martin.hoffman@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sodium concentration post administration of oral or IV hypertonic saline. (time frame: 1 hour post administration of hypertonic saline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2010.