Vitamin B3 for Healthy Volunteers

Recruiting at 1 trial location

Overseen By Nathan H Raines, MD MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Exercise limitations, Vitamin B3 allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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?

Research Team

Nathan H Raines, MD MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for healthy individuals interested in how their kidneys respond to heat stress. Participants should be willing to exercise under different temperature conditions and take Vitamin B3 as part of the study.

Inclusion Criteria

Healthy volunteer

Estimated glomerular filtration rate greater than 90 ml/min/1.73m2

Physically active, defined as doing at least 150 minutes of physical activity in an average week

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1: Heat Stress Exercise

Participants exercise in a hot and humid chamber at progressively higher intensities over three sessions

3 weeks

3 visits (in-person)

Stage 2: Heat Stress with Vitamin B3/Placebo

Participants exercise in the same chamber with vitamin B3 or placebo over two sessions

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after heat stress exposure

4 weeks

Treatment Details

Interventions

• Vitamin B3

Trial Overview The study is testing the kidney's response to exercise in hot environments and whether taking Vitamin B3 can influence this response, focusing on body chemicals and NAD+ metabolism during heat stress.

Participant Groups

Group I: Vitamin B3, then placebo Experimental Treatment 1 Intervention

Individuals will receive 1000mg oral Vitamin B3 daily for 2 days leading up to their first exercise session, and oral placebo daily for 2 days leading up to their second exercise session.

Group II: Placebo, then vitamin B3 Experimental Treatment 1 Intervention

Individuals will receive 1000mg oral placebo daily for 2 days leading up to their first exercise session, and oral vitamin B3 daily for 2 days leading up to their second exercise session.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Boston University Charles River Campus

Collaborator

Trials

125

Recruited

14,100+