Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07579429
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clonal Cytopenia of Undetermined Significance
  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicotinamide Riboside — DRUG
    Nicotinamide riboside is an orally administered dietary supplement and a vitamin B3 derivative that serves as a precursor to nicotinamide adenine dinucleotide (NAD+).
  • Pterostilbene — DRUG
    Pterostilbene is an orally administered dietary supplement and a naturally occurring polyphenol structurally related to resveratrol.

Study Details

This is an open-label, phase 2 study for lower risk MDS and high risk CCUS patients who are transfusion independent. There will be two cohorts enrolled at the same time to measure the effect of nicotinamide riboside and pterostilbene at different doses. The primary goals of the study are: * to assess if study drug improves cytopenias in patients * to determine safety of the study drug in patients

Key Dates

Start date
May 20, 2026
Status verified
Jun 2026
Primary completion
Dec 18, 2029
Completion
Dec 18, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nicotinamide Riboside and Pterostilbene - Low Dose
    Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg once daily for up to 12 months.
  • Experimental: Nicotinamide Riboside and Pterostilbene - High Dose
    Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg twice daily for up to 12 months.

Primary Outcome Measure

Preliminary Efficacy: Cytopenia Improvement [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Derek Schatz
[email protected]
(720) 848-0628
Maria Amaya, PhD MD (PRINCIPAL_INVESTIGATOR)
Matthew Angelos, MD (SUB_INVESTIGATOR)
Steven Bair, MD (SUB_INVESTIGATOR)
Cassandra Duarte, MD (SUB_INVESTIGATOR)
Jonathan Gutman, MD (SUB_INVESTIGATOR)
Bradley Haverkos, MD (SUB_INVESTIGATOR)
Manali Kamdar, MD (SUB_INVESTIGATOR)
Andrew Kent, MD (SUB_INVESTIGATOR)
Ajay Major, MD (SUB_INVESTIGATOR)
Christine McMahon, MD (SUB_INVESTIGATOR)
Jorge Monge-Urrea, MD (SUB_INVESTIGATOR)
Daniel Pollyea, MD (SUB_INVESTIGATOR)
Daniel Sherbenou, MD (SUB_INVESTIGATOR)

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By research site
University of Colorado Hospital· Aurora, CO

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