Recruiting
Early Phase 1

NAD+ Metabolism

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06983730

Conditions

Heat Strain

Healthy Volunteer Study

Kidney Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Vitamin B3

Study Details

Brief summary:

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?

Conditions

Heat Strain

Healthy Volunteer Study

Kidney Dysfunction

Study ID

NCT06983730

Start date

Jan 26, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vitamin B3, then placebo

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

experimental: Placebo, then vitamin B3

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

Interventions

Vitamin B3

1000mg once a day orally for two days, once the day before the exercise session, and once the day of the exercise session.

Primary outcome measure

  • Urinary neutrophil gelatinase-associated lipocalin [ Time Frame: Pre- and immediately post- heat stress exposure ]
  • Urinary TIMP2 (tissue inhibitor of metalloproteinase-2) and IGFBP7 (insulin-like growth factor-binding protein 7) [ Time Frame: Pre- and immediately post- heat stress exposure ]

Central Contacts and Locations

Central contacts

Nathan H Raines, MD MPH

703-927-0992nraines@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Nathan H Raines, MD MPH

703-927-0992nraines@bidmc.harvard.edu

Principal Investigator:

Nathan H Raines, MD MPH

Boston University

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Dustin Allen, PhD

417-693-2182drallen@bu.edu

Principal Investigator:

Dustin Allen, PhD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • NAD+
  • Niacinamide
  • Vitamin B3
  • Experimental heat strain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-02-05.