Nicotinamide Riboside + Pterostilbene for Myelodysplastic Syndrome

(ROSS Trial)

DS
Overseen ByDerek Schatz
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining nicotinamide riboside and pterostilbene can improve low blood cell counts in individuals with certain blood disorders. The goal is to determine if these supplements can safely enhance blood health in patients with lower-risk myelodysplastic syndrome (MDS) or high-risk clonal cytopenia of undetermined significance (CCUS). Participants will receive different daily doses of these treatments. Individuals managing lower-risk MDS or high-risk CCUS without requiring regular blood transfusions might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nicotinamide riboside and pterostilbene are generally safe for people. Studies have found that taking these compounds together can improve important blood levels without causing major side effects. For instance, one study reported that even at high doses—up to 1000 mg of nicotinamide riboside and 200 mg of pterostilbene taken twice a day—participants did not experience any serious negative effects. Another study confirmed that these supplements are safe and may even help reduce liver inflammation. Overall, previous research supports the safety of these treatments in humans.12345

Why are researchers excited about this trial's treatments?

Nicotinamide Riboside combined with Pterostilbene is intriguing because it targets cellular health in a unique way compared to standard treatments for Myelodysplastic Syndrome, which typically include lenalidomide, azacitidine, or decitabine. These compounds work by enhancing mitochondrial function and boosting NAD+ levels, which are crucial for cellular repair and longevity. The treatment offers a novel approach by potentially addressing the underlying cellular dysfunctions rather than just managing symptoms. Additionally, the oral administration of these compounds makes the treatment more convenient for patients, potentially improving adherence and quality of life.

What evidence suggests that this trial's treatments could be effective for Myelodysplastic Syndrome?

This trial will evaluate the effects of combining nicotinamide riboside and pterostilbene at different dosages for patients with myelodysplastic syndrome (MDS). Research has shown that this combination can effectively increase NAD+ levels, which are crucial for cell energy and health. One study found that NAD+ levels increased by about 40% in a group taking a lower dose and by about 90% in a group taking a higher dose. This increase is significant because some cells in MDS rely on NAD for energy, and enhancing this process might help improve symptoms. Additionally, this treatment has shown promise in slowing disease progression and improving symptoms in conditions like ALS, which affects the nervous system. These early findings suggest potential benefits for patients with MDS, but further research is needed to confirm these effects.13678

Who Is on the Research Team?

MA

Maria Amaya, PhD MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults (18+) with lower-risk myelodysplastic syndrome (MDS) or high-risk clonal cytopenia who do not need blood transfusions. Participants must have good kidney and liver function, be able to follow study procedures, and use effective birth control if needed.

Inclusion Criteria

I am 18 years old or older.
For persons of reproductive potential, use of highly effective method(s) of contraception
Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit
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Exclusion Criteria

Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load
Pregnant or breast-feeding females. A pregnancy test will be obtained at the time of screening if applicable
Known or suspected hypersensitivity to nicotinamide riboside and pterostilbene
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive nicotinamide riboside and pterostilbene at specified doses for up to 12 months

12 months
Study visits every 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Bone Marrow Assessment

Bone marrow biopsies performed to assess responses and conduct correlative studies

180 days
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotinamide Riboside
  • Pterostilbene

Trial Overview

The study tests two supplements—nicotinamide riboside and pterostilbene—at different doses to see if they improve low blood counts in MDS or CCUS patients. It’s an open-label phase 2 trial with two groups enrolled at the same time.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Nicotinamide Riboside and Pterostilbene - Low DoseExperimental Treatment2 Interventions
Group II: Nicotinamide Riboside and Pterostilbene - High DoseExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Cancer League of Colorado

Collaborator

Trials
13
Recruited
450+

Citations

Research On Nicotinamide Riboside Supplement Support ...

This is an open-label, phase 2 study for lower risk MDS and high risk CCUS patients who are transfusion independent.

Repeat dose NRPT (nicotinamide riboside and pterostilbene ...

This study shows that a repeat dose of NRPT is a safe and effective way to increase NAD + levels sustainably.

A Combination Treatment Has Promising Effects In ALS ...

Clinical trial shows that nicotinamide riboside (NR) and pterostilbene treatment slowed the progression of ALS and even improved symptoms.

Nicotinamide riboside and pterostilbene reduces frequency ...

In the present study, the effects of a 7-day supplementation of NRPT on undesirable symptoms of the menopause transition were examined. Methods: An open-label, ...

Repeat dose NRPT (nicotinamide riboside and ...

NAD⁺ levels increased by approximately 40% in the NRPT 1X group and approximately 90% in the NRPT 2X group after 4 weeks as compared to placebo and baseline.

Nicotinamide riboside with pterostilbene (NRPT) increases ...

NRPT increases whole blood NAD + levels in hospitalized patients with AKI. In addition, NRPT up to a dose of 1000 mg/200 mg twice a day for 2 days is safe and ...

Repeat dose NRPT (nicotinamide riboside and ...

This study shows that a repeat dose of NRPT is a safe and effective way to increase NAD+ levels sustainably.

Combination of natural polyphenols with a precursor ...

The combination of pterostilbene (PT) and silibinin (SIL) was the most effective against γ-irradiation, resulting in 100% of the mice surviving at 30 days and ...