What this study is
The goal of this clinical trial is to learn about the processes occurring in the kidneys while under heat stress in healthy volunteers. The main questions it aims to answer are:
- How do the chemicals produced by the body change under conditions of higher versus lower heat stress?
- What role does a specific area of the body's metabolism, known as NAD+ metabolism, play in the body's response to heat stress, and can this response be modified by taking vitamin B3?
What's being tested
- Vitamin B3
Intervention · DIETARY SUPPLEMENT
1000mg once a day orally for two days, once the day before the exercise session, and once the day of the exercise session.
Study details
- Official title
- Development of a Clinical Experimental Heat Stress Protocol and Exploration of the Effect of Niacinamide on Physiologic, Metabolic, and Biochemical Responses to Heat Stress
- Sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Heat Strain · Healthy Volunteer Study · Kidney Dysfunction
- Enrolling
- 28 people
- Starts
- 2026-01-26
- Est. completion
- 2028-06
- Design
- Quadruple-blind, randomized, crossover, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Healthy volunteer
- Any race
- Estimated glomerular filtration rate greater than 90 ml/min/1.73m2
- Urine albumin/creatinine ratio less than 30mg/g
- Nonsmoker
- No regular dietary supplements, particularly vitamin B3
- Physically fit, defined as having a VO2 max of between 35 and 60mL/kg/min
You can't join if
- Medical condition preventing safe participation in exercise during heat
- Allergy to Vitamin B3
- Severe food allergies or dietary restrictions that would preclude eating the planned study diet without major modifications
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Nathan H Raines, MD MPH · Contact703-927-0992nraines@bidmc.harvard.edu
- Nathan H Raines, MD MPH · Principal investigator
RecruitingBoston University
Boston, Massachusetts, United States
- Dustin Allen, PhD · Contact417-693-2182drallen@bu.edu
- Dustin Allen, PhD · Principal investigator
Recruiting
Study team
Sponsor
Beth Israel Deaconess Medical Center
Study ID 2024P000637
Principal investigator
Nathan H Raines, MD MPH
Beth Israel Deaconess Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.