Nicotinamide Riboside for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

Overseen by Kevin Mollen

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Must not be taking: Steroids, Antibiotics

Disqualifiers: Severe ulcerative colitis, Crohn's, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, patients on biologic medications can join if their dose has been stable for at least three months. After starting the study, you can continue any medication as advised by your doctor.

What data supports the effectiveness of the drug Nicotinamide Riboside Chloride for treating ulcerative colitis?

Research on a similar compound, nicotinamide mononucleotide (NMN), shows it can improve intestinal inflammation and gut health in mice with colitis, suggesting potential benefits for similar conditions. Additionally, Nicotinamide Riboside (NR) is known to increase NAD+ levels, which may support cellular health and repair. ^{1 2 3 4 5}

Is nicotinamide riboside safe for human use?

Nicotinamide riboside, a form of vitamin B3, has been studied for safety and is generally recognized as safe for use in foods and supplements. Human studies show no significant safety concerns, and it is considered safe for healthy adults at certain doses, though caution is advised for pregnant and lactating women. ^{4 6 7 8 9}

How does the drug Nicotinamide Riboside Chloride differ from other treatments for ulcerative colitis?

Nicotinamide Riboside Chloride is unique because it is a form of vitamin B3 that boosts NAD+ levels, which is important for various metabolic processes. Unlike traditional treatments for ulcerative colitis, which often focus on reducing inflammation directly, this drug may offer benefits by enhancing cellular energy and metabolism, potentially impacting inflammation indirectly. ^{4 6 10 11 12}

Research Team

Kevin Mollen

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for children and teenagers (≤18 years old) with mild to moderate ulcerative colitis. It's open to those newly diagnosed or with established disease, but not if they have severe UC, other gastrointestinal infections, Crohn's disease, certain other inflammatory conditions, recent steroid/antibiotic use, or kidney/liver problems.

Inclusion Criteria

Although the investigators will target newly diagnosed patients (therefore, treatment naïve), patients with established disease will also be enrolled

I am 18 years old or younger.

I have been diagnosed with mild to moderate ulcerative colitis.

Exclusion Criteria

I have kidney or liver problems.

My condition is diagnosed as indeterminate colitis or IBD-U.

I am not pregnant and will use contraception if of childbearing age.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 years

Treatment

Participants receive daily oral therapy with either Nicotinamide Riboside Chloride or placebo, alongside standard therapy

6-12 months

Colonoscopic evaluations at enrollment and after 6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nicotinamide Riboside Chloride (Dietary Supplement)
• Placebo (Dietary Supplement)
• Standard of Care (Other)

Trial Overview The study tests Nicotinamide Riboside Chloride in young patients with Ulcerative Colitis against a placebo while maintaining standard care. Participants are randomly assigned to either the test drug or placebo without knowing which one they receive.

Participant Groups

Group I: Daily oral therapy with placebo + Standard Therapy Experimental Treatment 2 Interventions

Placebo 75mg or 250mg capsules provided by ChromaDex, Inc. Dosing is recommended at 12.5mg/kg/day. The dosing plan is as follows (in mg po qD): 20-25 kg 250mg; 25-30 kg 325mg; 30-35 kg 400mg; 35-40 kg 475mg; 40-45 kg 500mg; 45-50 kg 575mg; 50-55 kg 650mg; 55-60 kg 725mg; 60-65 kg 750mg; 65-70 kg 825mg; \>70 kg 900mg (max dosing).

Group II: Daily oral therapy with Nicotinamide Riboside Chloride (Niagen) + Standard Therapy Experimental Treatment 2 Interventions

Nicotinamide Riboside Chloride (Niagen) 75mg or 250mg capsules provided by ChromaDex, Inc. Dosing is recommended at 12.5mg/kg/day. The dosing plan is as follows (in mg po qD): 20-25 kg 250mg; 25-30 kg 325mg; 30-35 kg 400mg; 35-40 kg 475mg; 40-45 kg 500mg; 45-50 kg 575mg; 50-55 kg 650mg; 55-60 kg 725mg; 60-65 kg 750mg; 65-70 kg 825mg; \>70 kg 900mg (max dosing).

Nicotinamide Riboside Chloride is already approved in Canada for the following indications:

Approved in Canada as Nicotinamide Riboside Chloride for:

• Licensed Natural Health Products

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UPMC Children's Hospital of Pittsburgh Pittsburgh, PA

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1820

Patients Recruited

16,360,000+

Crohn's and Colitis Foundation

Collaborator

Trials

44

Patients Recruited

27,500+

Findings from Research

Mesalamine has been shown to effectively induce remission in patients with active ulcerative colitis, with doses of 2 g/d and 4 g/d outperforming placebo, and rectal mesalamine achieving a 78% remission rate in patients with prior steroid treatment.

In contrast, while mesalamine reduced the relapse rate in inactive Crohn's disease from 71% to 55%, nicotine was found to have adverse effects on Crohn's disease and is not recommended for treatment, indicating that mesalamine is the more reliable option for managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mesalamine and nicotine in the treatment of inflammatory bowel disease. Bonapace, CR., Mays, DA.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside Preserves Ovarian Injury in Experimental Sepsis Model in Rats. Selli, J., Vural Keles, D., Keles, ON., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of inflammatory bowel disease: Potential effect of NMN on intestinal barrier and gut microbiota. Huang, P., Wang, X., Wang, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Conze, D., Brenner, C., Kruger, CL.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide treatment ameliorates the course of experimental colitis mediated by enhanced neutrophil-specific antibacterial clearance. Bettenworth, D., Nowacki, TM., Ross, M., et al.[2014]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. Turck, D., Castenmiller, J., de Henauw, S., et al.[2020]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283. Turck, D., Bohn, T., Castenmiller, J., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Novel Triazole-Based Nicotinamide Phosphoribosyltransferase (NAMPT) Inhibitors Endowed with Antiproliferative and Antiinflammatory Activity. Travelli, C., Aprile, S., Rahimian, R., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in Intestinal Brush Border Membrane Functionality and Bacterial Populations Following Intra-Amniotic Administration (Gallus gallus) of Nicotinamide Riboside and Its Derivatives. Kolba, N., Zarei, A., Cheng, J., et al.[2022]

References

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

The effect of mesalamine and nicotine in the treatment of inflammatory bowel disease. [2017]

2. Turkey pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside Preserves Ovarian Injury in Experimental Sepsis Model in Rats. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of inflammatory bowel disease: Potential effect of NMN on intestinal barrier and gut microbiota. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Nicotinamide treatment ameliorates the course of experimental colitis mediated by enhanced neutrophil-specific antibacterial clearance. [2014]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. [2020]

8. 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]

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

Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Identification of Novel Triazole-Based Nicotinamide Phosphoribosyltransferase (NAMPT) Inhibitors Endowed with Antiproliferative and Antiinflammatory Activity. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Alterations in Intestinal Brush Border Membrane Functionality and Bacterial Populations Following Intra-Amniotic Administration (Gallus gallus) of Nicotinamide Riboside and Its Derivatives. [2022]