Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat

NCT ID: NCT06247462

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-09-05

Brief Summary

The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Ibuprofen

600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise.

Group Type: EXPERIMENTAL

Ibuprofen 600 mg

Intervention Type: DRUG

600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.

Placebo (Corn Starch)

600 mg of corn starch was ingested 12- and 1-hour prior to exercise.

Group Type: PLACEBO_COMPARATOR

Placebo Corn Starch

Intervention Type: DRUG

600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.

Interventions

Ibuprofen 600 mg

600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.

Intervention Type: DRUG

Placebo Corn Starch

600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Physically active (engage in at least 150 minutes of moderate to vigorous intensity exercise per week)
• between the ages of 18 and 45
• Able to run continuously for at least 60 minutes
• Able to speak and read English.

Exclusion Criteria

• Non-English speakers, prisoners, pregnant women, or persons requiring a LAR
• Previous history of heat stroke or heat illness
• Currently experiencing a sunburn or other burn injury
• Have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment
• Has resided in a hot climate within 2 months prior to the trial
• Answered "yes" to at least one question on the physical activity readiness questionnaire
• Shows signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire
• Are a current smoker
• History of regular gastrointestinal distress
• Known history of stomach ulcers or taking blood thinning medication
• Known allergy to ibuprofen
• Have a resting blood pressure greater than 140 systolic or 90 diastolic
• Do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Exercise Physiology Lab

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

IBU2023

Identifier Type: -

Identifier Source: org_study_id