Vitamin B3 for Healthy Volunteers

Not yet 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

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

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 for a Trial Participant

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

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?

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+

Citations

1. ods.od.nih.gov ods.od.nih.gov/factsheets/Niacin-HealthProfessional/

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.aspx

Niacin 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 ...

3. nature.com nature.com/articles/s41598-024-79986-9

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.

4. nutritionsource.hsph.harvard.edu nutritionsource.hsph.harvard.edu/niacin-vitamin-b3/

Niacin – Vitamin B3 - The Nutrition Source Clinical trials have not consistently shown that nicotinic acid leads to less cardiovascular events or deaths from CVD.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2730481

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC280687/

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.

7. mayoclinic.org mayoclinic.org/drugs-supplements-niacin/art-20364984

Niacin Experts believe niacin to be safe when taken by mouth in typical amounts. High doses of prescription niacin can cause: Skin flushing and ...

8. aao.org aao.org/eye-health/tips-prevention/vitamin-b3-nicotinamide-glaucoma

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 ...

9. webmd.com webmd.com/diet/supplement-guide-niacin

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, ...