Vitamin B3 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how heat stress affects the kidneys in healthy individuals and whether vitamin B3 alters the body's response to heat. Researchers aim to understand changes in body chemicals due to heat and the role of NAD+ metabolism in the body's energy process. Participants will take either vitamin B3 or a placebo before exercise sessions to observe any differences. Healthy, non-smoking individuals who exercise regularly and do not take vitamin B3 supplements are eligible to participate. As an Early Phase 1 trial, this research seeks to understand how vitamin B3 functions in people, offering participants the opportunity to contribute to groundbreaking insights.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot take regular dietary supplements, especially vitamin B3, during the trial.
Is there any evidence suggesting that vitamin B3 is likely to be safe for humans?
Research shows that vitamin B3 is generally safe for most people when taken in normal amounts. Studies indicate that low doses are usually well-tolerated. However, higher doses, like those used to treat certain health conditions, can sometimes cause side effects, including skin flushing (a warm, red feeling on the skin), headaches, and dizziness. Very high doses might lead to more serious issues, such as liver problems, though these are uncommon when vitamin B3 is used correctly.
In this trial, participants will take 1000 mg of vitamin B3 for a short time. Although this exceeds the usual dietary intake, the study is in its early stages, focusing on safety and effects. Participants should be aware of possible side effects and report any discomfort to the study team.12345Why are researchers excited about this trial's treatment?
Researchers are excited about using Vitamin B3 in new ways because it offers potential benefits that differ from standard treatments. Unlike typical vitamin supplements that are taken for general health, this approach investigates Vitamin B3's role in enhancing exercise performance. By possibly improving energy metabolism, Vitamin B3 could help the body use energy more efficiently during physical activity. This could lead to better endurance and recovery, offering a fresh angle that might interest both athletes and those looking to optimize their exercise routines.
What evidence suggests that vitamin B3 might be an effective treatment for heat stress?
Research has shown that Vitamin B3, also known as niacin, helps the body convert food into energy by producing a molecule called NAD+. While Vitamin B3 generally benefits health, scientists continue to study its effects on the kidneys under heat stress. Some studies suggest that increased niacin intake might lower the risk of death from heart disease, though results vary. This trial will explore how Vitamin B3 might enhance the body's ability to handle heat through its role in NAD+ production. Participants will receive either Vitamin B3 or a placebo in different sequences to assess its effects. Early findings indicate it could alter the body's response to heat, but further research is necessary to confirm this.26789
Who Is on the Research Team?
Nathan H Raines, MD MPH
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1: Heat Stress Exercise
Participants exercise in a hot and humid chamber at progressively higher intensities over three sessions
Stage 2: Heat Stress with Vitamin B3/Placebo
Participants exercise in the same chamber with vitamin B3 or placebo over two sessions
Follow-up
Participants are monitored for safety and effectiveness after heat stress exposure
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Boston University Charles River Campus
Collaborator
Citations
Niacin - Health Professional Fact Sheet
Niacin (Vit B3) overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions here.
2.
journals.lww.com
journals.lww.com/pn/fulltext/2025/09000/niacin_supplementation_and_mortality_in_the_us.3.aspxNiacin supplementation and mortality in the US population:...
Niacin supplement doses below 20 mg/day were associated with a decreased mortality risk, while doses above 100 mg/day were associated with an increased ...
Association of dietary niacin intake with all-cause and ...
In this population-based cohort study, higher dietary niacin intake correlates with lower risk of all-cause and cardiovascular mortality among US adults.
Niacin – Vitamin B3 - The Nutrition Source
Clinical trials have not consistently shown that nicotinic acid leads to less cardiovascular events or deaths from CVD.
Assessment of the Role of Niacin in Managing ...
17 trials reported niacin's effect on cardiovascular outcomes and did not suggest that niacin prevents cardiovascular disease overall.
The safety of over-the-counter niacin. A randomized placebo ...
We sought to determine the safety of 500 mg immediate release niacin, when healthy individuals use them as directed.
Niacin
Experts believe niacin to be safe when taken by mouth in typical amounts. High doses of prescription niacin can cause: Skin flushing and ...
Nicotinamide Safety Concerns
Skin flushing can happen if you take 30mg or more. Headaches, dizziness, decreased blood pressure, and other serious problems such as liver ...
Niacin (Vitamin B3): Benefits and Side Effects
At the low dietary reference intake (DRI) doses, niacin is safe for everyone. However, at the higher amounts used to treat medical conditions, ...
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