---
title: "The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response"
nct_id: NCT06983730
overall_status: RECRUITING
phase: EARLY_PHASE1
sponsor: Beth Israel Deaconess Medical Center
study_type: INTERVENTIONAL
primary_condition: Heat Strain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06983730.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06983730"
ct_last_update_post_date: 2026-02-05
last_seen_at: "2026-05-12T07:17:26.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response

**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

**NCT ID:** [NCT06983730](https://clinicaltrials.gov/study/NCT06983730)

## Key Facts

- **Status:** RECRUITING
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Beth Israel Deaconess Medical Center
- **Collaborators:** Boston University Charles River Campus, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- **Conditions:** Heat Strain, Healthy Volunteer Study, Kidney Dysfunction
- **Start Date:** 2026-01-26
- **Completion Date:** 2028-06
- **CT.gov Last Update:** 2026-02-05

## 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?

## Detailed Description

To answer these questions, researchers will compare the chemical changes in each participant under progressively higher levels of heat stress, and while taking either vitamin B3 or a placebo.

This clinical trial will occur in two stages. Participants may choose participate in stage 1 only, stage 2 only, or both parts of this clinical trial.

During stage 1, participants will exercise using a stationary rowing ergometer in a hot and humid environmental chamber for three sessions, each session separated by about a week.

* Each session, they will be asked to work out at a progressively higher intensity with climate conditions kept the same in the chamber.
* More intense exercise produces greater heat stress, resulting in lower, moderate, and higher levels of heat stress exposure across the three sessions.
* Researchers will see how chemicals in the blood and urine, along with physical measurements like heart rate and body temperature, change across these different levels of heat stress.

During stage 2, participants will exercise using the same rowing ergometer in the same environmental chamber. They will do this for two sessions, each separated by about a week.

* One of the sessions each participant will take vitamin B3, and the other session each participant will take placebo.
* Heat stress exposure will be the same each session.
* Researchers will again see how chemicals in the blood and urine, along with physical measurements like heart rate and body temperature, differ between sessions with vitamin B3 and sessions with placebo

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **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.
- **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.

## 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.

## Primary Outcomes

- **Urinary neutrophil gelatinase-associated lipocalin** _(time frame: Pre- and immediately post- heat stress exposure)_ — Marker of stress and injury in the kidney
- **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)_ — Marker of kidney stress and injury

## Secondary Outcomes

- **Urine Quinolinate to Tryptophan Ratio** _(time frame: Pre- and immediately post- heat stress exposure)_
- **Serum creatinine** _(time frame: Pre- and immediately post- heat stress exposure)_

## Locations (2)

- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States — _RECRUITING_
- Boston University, Boston, Massachusetts, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beth israel deaconess medical center|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.boston university|boston|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06983730.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06983730*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*