Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration

Overseen By Ahmet Hoke, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Disqualifiers: Diabetes, HIV, Chemotherapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if a nutritional supplement called nicotinamide riboside can prevent and repair nerve damage caused by applying capsaicin to the skin in healthy people. The study aims to see if this supplement can help nerves stay healthy and grow back after damage.

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, if you have any conditions like diabetes or are undergoing chemotherapy, you may not be eligible to participate.

What makes Nicotinamide Riboside (NR) unique as a treatment?

Nicotinamide Riboside (NR) is unique because it is a form of vitamin B3 that elevates NAD+ levels more effectively than other forms, potentially offering benefits for age-related disorders and various metabolic, cardiovascular, and neurodegenerative conditions. ^{1 2 3 4 5}

Research Team

Ahmet Hoke

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

Neurological examination reveals no impairment.\n

Age: 18-65

You have a body mass index (BMI) of less than 32.

Exclusion Criteria

You have a history of nerve damage, often in the hands or feet.

Any peripheral neuropathy risk factor including diabetes, Vitamin B12 deficiency, HIV-infection, chronic kidney or hepatic disease, hypothyroidism, chemotherapy or other know neurotoxic exposure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Nicotinamide Riboside or placebo to evaluate prevention of nerve degeneration and promotion of nerve regeneration

3 months

Bi-weekly visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nicotinamide Riboside
• Placebo Oral Tablet

Participant Groups

Group I: Nicotinamide Riboside Experimental Treatment 1 Intervention

Experimental group of participants will receive Nicotinamide riboside at a dose of 900 mg twice a day orally.

Group II: Placebo Placebo Group 1 Intervention

Study participants in the placebo arm will receive placebo pills that are similar in size and shape to the experimental group drug.

Nicotinamide Riboside is already approved in United States, European Union for the following indications:

Approved in United States as Niagen for:

• Dietary supplement for general health and wellness

Approved in European Union as Niagen for:

• Dietary supplement for general health and wellness

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Adelson Medical Research Foundation

Collaborator

Trials

1

Recruited

50+

Findings from Research

Cow milk is a significant source of nicotinamide riboside (NR), containing approximately 12 μmol of NAD(+) precursor vitamins per liter, with NR making up about 40% of this concentration.

The presence of Staphylococcus aureus in milk negatively impacts NR levels, suggesting that controlling this bacteria is crucial for maintaining the nutritional quality of milk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside Is a Major NAD+ Precursor Vitamin in Cow Milk. Trammell, SA., Yu, L., Redpath, P., et al.[2023]

Nicotinamide riboside (NR) is a form of vitamin B3 that effectively increases NAD+ levels, which may help counteract age-related declines in this important metabolite.

In a 90-day safety study on Sprague Dawley rats, NR-E showed no significant adverse effects at doses up to 1,200 mg/kg/d, establishing a no-observed-adverse-effect-level (NOAEL) of 500 mg/kg/d for males and 1,200 mg/kg/d for females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Assessment of High-Purity, Synthetic Nicotinamide Riboside (NR-E) in a 90-Day Repeated Dose Oral Toxicity Study, With a 28-Day Recovery Arm. Marinescu, AG., Chen, J., Holmes, HE., et al.[2021]

Nicotinamide riboside (NR) is a promising NAD+ precursor that has shown potential health benefits in treating various conditions, including cardiovascular, neurodegenerative, and metabolic disorders, based on numerous animal and human studies.

Research indicates that NR may also have therapeutic applications against infections, such as SARS-CoV-2, but challenges related to its bioavailability and safety need to be addressed for effective translation into clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. Mehmel, M., Jovanović, N., Spitz, U.[2021]

Nicotinamide riboside (NR), a form of vitamin B3, was found to be safe in various toxicity studies, including a 90-day rat study, with no genotoxic effects and no mortality at high doses (5000 mg/kg).

The lowest observed adverse effect level for NR was determined to be 1000 mg/kg/day, indicating that while it is generally safe, higher doses may lead to toxicity in organs such as the liver and kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of nicotinamide riboside, a form of vitamin B3. Conze, DB., Crespo-Barreto, J., Kruger, CL.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside Is a Major NAD+ Precursor Vitamin in Cow Milk. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Syntheses and chemical properties of β-nicotinamide riboside and its analogues and derivatives. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Safety Assessment of High-Purity, Synthetic Nicotinamide Riboside (NR-E) in a 90-Day Repeated Dose Oral Toxicity Study, With a 28-Day Recovery Arm. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Safety assessment of nicotinamide riboside, a form of vitamin B3. [2019]