Actively Recruiting
Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)
Led by University of Colorado, Denver · Updated on 2026-06-03
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
C
Cancer League of Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of nicotinamide riboside and pterostilbene supplements in patients with lower risk Myelodysplastic Syndrome (MDS) and high risk Clonal Cytopenia of Undetermined Significance (CCUS) who do not require blood transfusions. This open-label phase 2 study aims to determine whether these supplements can improve blood cell counts (cytopenias) and to assess their safety in these patients. Participants are divided into two groups receiving different doses of the supplements. One group takes nicotinamide riboside 250 mg and pterostilbene 50 mg once daily, while the other takes the same doses twice daily, for up to 12 months. Both groups begin treatment at the same time and have study visits every 90 days. Bone marrow biopsies are done at screening and after 180 days to evaluate changes in bone marrow cells and study related factors. Throughout the study, participants will undergo regular assessments to monitor blood counts, safety, and changes in genetic markers related to their condition. The main outcome is improvement in blood cell counts after 24 weeks. Safety data will be collected from enrollment until 30 days after the last dose, covering about 13 months in total. Additional measures include platelet and neutrophil responses, as well as genetic changes in bone marrow cells.
CONDITIONS
Brief Title
Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must voluntarily sign and date an informed consent before starting any study procedures.
- Willingness to comply with all study procedures and be available for the entire study duration.
- Male or female aged 18 years or older.
- Use of highly effective contraception for persons of reproductive potential.
- Confirmed diagnosis of high risk CCUS or lower risk MDS with IPSS-M less than 0.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Adequate kidney function with creatinine clearance of 30 mL/min or higher.
- Adequate liver function with AST and ALT less than or equal to 3 times the upper limit of normal and total bilirubin less than or equal to 3 times the upper limit of normal unless due to Gilbert's syndrome.
- Informed about prohibited fruit consumption during the study (grapefruit, Seville oranges, star fruit).
You will not qualify if you...
- Positive for HIV with uncontrolled disease.
- Positive for hepatitis B or C infection unless viral load is undetectable.
- History of significant cardiac disease within the last 6 months including severe heart failure, unstable angina, or recent heart attack.
- Presence of severe renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular diseases, or bleeding disorders unrelated to leukemia.
- Malabsorption syndrome or gastrointestinal conditions that interfere with drug absorption.
- Evidence of uncontrolled systemic infections requiring treatment.
- History of other cancers except certain treated localized carcinomas or surgically cured malignancies.
- Transfusion dependence or candidates for specific MDS therapies like erythroid stimulating agents or hypomethylating agents.
- Pregnant or breastfeeding females.
- Known or suspected allergy to nicotinamide riboside or pterostilbene.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including a bone marrow biopsy
Duration - Up to 12 months
Participants take oral nicotinamide riboside and pterostilbene supplements daily for up to 12 months.
Visits every 90 days with a bone marrow biopsy at 180 days
Duration - 30 days
Participants are monitored for safety for 30 days after the last dose of study drug.
1 visit (in-person) after treatment ends
Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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