Nicotinamide Riboside + Pterostilbene for Myelodysplastic Syndrome
(ROSS 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nicotinamide riboside and pterostilbene at specified doses for up to 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Bone Marrow Assessment
Bone marrow biopsies performed to assess responses and conduct correlative studies
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
Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg once daily for up to 12 months.
Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg twice daily for up to 12 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Cancer League of Colorado
Collaborator
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 ...
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