ROSS Trial: Nicotinamide Riboside and Pterostilbene for MDS and CCUS
This study, called the ROSS Trial, is looking at whether two dietary supplements, Nicotinamide Riboside and Pterostilbene, can help improve blood counts (cytopenias) in people with lower-risk Myelodysplastic Syndrome (MDS) or high-risk Clonal Cytopenia of Undetermined Significance (CCUS). These conditions affect how your body makes blood cells. You might be able to join if you are 18 or older, and your condition doesn't currently require blood transfusions. The main goal is to see if these supplements improve your blood counts after 24 weeks and to check their safety. The study is currently unclear on its recruitment status.
- Study design
- This is an open-label, Phase 2 study, meaning both you and the study team will know which treatment you are receiving. It will involve 10 participants divided into two groups, testing different doses of the supplements.
- What's involved
- You would take Nicotinamide Riboside and Pterostilbene daily for a year. You will have study visits every 90 days, and two bone marrow biopsies: one at the start and one after 180 days of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome for improvement in blood counts is measured at 24 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07579429
Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Colorado, DenverInvestigator-initiated
~10 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Nicotinamide RibosidePterostilbene
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Preliminary Efficacy: Cytopenia Improvement
Measured over 24 weeks
Conditions
Where it's being run
1 sites across 1 statesColorado1
Study leadership
- Maria Amaya, PhD MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed procedures.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Be a male or female aged ≥ 18 years of age.
For persons of reproductive potential, use of highly effective method(s) of contraception.
Subject must have confirmation of high risk CCUS (defined by CHRS score) or the diagnosis of MDS in the lower risk category as defined by IPSS-M less than 0.
Patients must have ECOG of ≤ 2
Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
Subject must have adequate liver function as demonstrated by:
aspartate aminotransferase (AST) ≤ 3.0 × ULN
alanine aminotransferase (ALT) ≤ 3.0 × ULN
Unless due to Gilbert's syndrome, patients must have a total bilirubin ≤ 3 × ULN.
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.
Exclusion
Subject is known to be positive for HIV with uncontrolled disease. HIV testing is not required.
Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV may participate.
Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \> class 2, unstable angina, or myocardial infarction.
Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.
Subject has a history of other malignancies prior to study entry, with the exception of:
Adequately treated in situ carcinoma of the breast or cervix uteri
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
Prostate cancer not requiring therapy beyond hormonal therapy
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Any subject who is transfusion dependent and a candidate for MDS therapy such as erythroid stimulating agents, thrombopoietin receptor agonists, Lusparercept, Imetelstat or hypomethylating agents.
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.
What this trial measures
- Preliminary Efficacy: Cytopenia Improvement24 weeks
To assess efficacy of nicotinamide riboside and pterostilbene supplementation by assessing whether it increased hemoglobin by 1g/dL in 24 weeks.