Recruiting

Kidney Health

Sponsor:

Arizona State University

Code:

NCT07519408

Conditions

AKI (Acute Kidney Injury) Due to Trauma

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Sodium Bicarbonate (NaHCO3)

Placebo

Study Details

Brief summary:

This study aims to understand how participating in the Western States Endurance Run (WSER), a 100-mile ultramarathon, affects kidney health. Long, strenuous exercise in hot conditions can temporarily strain the kidneys, especially when combined with dehydration, muscle breakdown, and the use of common pain-relief medications such as ibuprofen. Although kidney stress has been reported in endurance sports, no study has examined it directly in runners during the WSER using newer, more sensitive urine markers of kidney injury. Runners who volunteer will complete brief assessments before and after the race. These include providing a urine sample, a small finger-prick blood sample, a body-weight measurement, and answering a short questionnaire about pain-medication use. During the race, participants will wear a global positioning system (GPS) watch and heart-rate strap to monitor effort. Each assessment takes about 15 minutes, and no follow-up is required. Findings from this study will help determine how often kidney stress occurs in this event and what factors may contribute to it, ultimately supporting safer training and medical practices for ultramarathon athletes.

Conditions

AKI (Acute Kidney Injury) Due to Trauma

Study ID

NCT07519408

Start date

Jun 27, 2026

Status verified date

Feb, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Running in the Western States Endurance Run in either 2026, 2027 or 2028
  • No contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire (PAR-Q+) as prepared by the American College of Sports Medicine (ACSM)
  • Not currently taking medicine or experiencing illness that may influence the cardiovascular or neuromuscular system
  • Age ≥18 and ≤ 50 years old and injury free (skeletal muscle) for > 3 months

Exclusion Criteria:

  • Minors (under 18)
  • Adults who are unable to consent (impaired decision-making capacity)
  • Prisoners
  • Pregnant Women
  • Individuals with known kidney disease, or are on any medication that specifically effects kidney function (e.g., diuretics)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: sodium bicarbonate

volunteers will be provided 0.3g/kg body weight of sodium bicarbonate to be consumed after completing the Western States Endurance Run (100 miles)

placebo comparator: placebo

volunteers will be provide 0.3g/kg body weight of placebo (corn starch) to be consumed after the race.

Interventions

Sodium Bicarbonate (NaHCO3)

SB will be used to investigate whether adding a buffer exogenously to aid recovery helps in reducing the severity of acute kidney injury.

Placebo

The placebo product consists of the same sodium concentration as the intervention group receiving sodium bicarbonate.

Primary outcome measure

  • tissue inhibitor of metalloproteinase 2 (TIMP-2) [ Time Frame: one hour prior to starting the race (baseline), immediately upon finishing the race (immediately post-race) and 24 from hours from the immediately post-race sample ]
  • neutrophil gelatinase-associated lipocalin (NGAL) [ Time Frame: one hour prior to starting the race (baseline), immediately upon finishing the race (immediately post-race) and 24 from hours from the immediately post-race sample ]
  • Cystatin C [ Time Frame: one hour prior to starting the race (baseline), immediately upon finishing the race (immediately post-race) and 24 from hours from the immediately post-race sample ]

Central Contacts and Locations

Locations

ASU Health Futures Center

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Jason Siegler, PhD

602-702-6075jason.siegler@asu.edu

More Information

Sponsor

Arizona State University

Last update posted

Nov 5, 2026

Last verified

Feb, 2026

Keywords

  • ultra-endurance
  • bicarbonate
  • AKI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.