The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response

NCT06983730 | Recruiting Early Phase 1 DMC

• 2 other identifiers: 2024P000637K23DK138320
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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

Keywords

NAD+; Niacinamide; Vitamin B3; Experimental heat strain

Outcome Measures

Primary Outcomes (2)

• Urinary neutrophil gelatinase-associated lipocalin

  Marker of stress and injury in the kidney

  Pre- and immediately post- heat stress exposure

• Urinary TIMP2 (tissue inhibitor of metalloproteinase-2) and IGFBP7 (insulin-like growth factor-binding protein 7)

  Marker of kidney stress and injury

  Pre- and immediately post- heat stress exposure

Secondary Outcomes (2)

• Urine Quinolinate to Tryptophan Ratio

  Pre- and immediately post- heat stress exposure

• Serum creatinine

  Pre- and immediately post- heat stress exposure

Other Outcomes (2)

• Urine and serum metabolites, including metabolites related to nicotinamide adenine dinucleotide (NAD+)

  Pre-, during, immediately post, and 24 hours post- heat stress exposure

• Urine and serum nicotinamide levels

  Pre-, during, immediately post, and 24 hours post- heat stress exposure

Study Arms (2)

Vitamin B3, then placebo

EXPERIMENTAL

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.

Dietary Supplement: Vitamin B3

Placebo, then vitamin B3

EXPERIMENTAL

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.

Dietary Supplement: Vitamin B3

Interventions

Vitamin B3 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.

Also known as: niacinamide

Placebo, then vitamin B3; Vitamin B3, then placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You 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 may not qualify 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston University Charles River Campus: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Interventions

Niacinamide

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nathan H Raines, MD MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan H Raines, MD MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: There are two phases to this study. The first phase is a dose-response phase evaluating the effect of experimental heat strain on kidney metabolic and stress response. The second phase uses this experimental heat strain at a dose producing kidney metabolic and stress response to conduct a crossover trial investigating how Vitamin B3 impacts the kidney's metabolic and stress response during heat strain.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 21, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data availability will begin at the time of an associated publication or the end of the performance period, whichever comes first. Data will continue to be available for ten years after completion of study activities.
• Access Criteria: Researchers may request controlled-access data using standard processes at the repository.

Locations

US (2)