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NCT03682029 · ClinicalTrials.gov registry record · NA
Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies
A NA study of Myelodysplastic Syndromes and Cytopenia, sponsored by Rigshospitalet, Denmark.
- Active
- Registry status
- NA
- Development phase
- 109
- Enrollment target
- 5
- Study locations
NCT03682029: Active NA study of Myelodysplastic Syndromes and Cytopenia, sponsored by Rigshospitalet, Denmark.
NCT03682029 is a NA study of Myelodysplastic Syndromes and Cytopenia that is active but no longer recruiting, run by Rigshospitalet, Denmark. The registered enrollment target is 109 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (62% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03682029, a NA study of Myelodysplastic Syndromes and Cytopenia, is active but no longer recruiting, sponsored by Rigshospitalet, Denmark.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 109 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary purpose of this multi-centre, randomized, placebo-controlled, double-blind phase II study is to investigate if oral vitamin C may change the biology of low-risk myeloid malignancies; i.e., clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)-0/1 by reversing the epigenetic changes characteristic of these disease entities. The epigenetic regulator TET2 is the gene most often affected in CCUS. Preclinical studies have shown that active demethylation by the TET enzymes is dependent on vitamin C, and the investigators and collaborators have shown that plasma vitamin C levels are exceedingly low in hematological cancer patients but are easily corrected by oral vitamin C. This study is part of an array of EVITA studies aimed at clarifying whether the standard of care of patients with myeloid malignancies should be changed and oral vitamin C supplement added to the treatment recommendations.
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Vitamin C (ascorbic acid)
Study Locations (5)
Other
- Aalborg University Hospital - Aalborg
- Herlev University Hospital - Copenhagen
- Odense University Hospital - Odense
California
- Keck Hospital of University of Southern California - Los Angeles
N/A = Not Applicable
- Rigshospitalet - Copenhagen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2017-11-21 |
| Est. Completion | 2025-09-27 |
| Phase | NA |
What the registry record for NCT03682029 still lists
NCT03682029 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03682029 lists 5 locations in 3 states (Other, California, N/A = Not Applicable).
Frequently Asked Questions
What is clinical trial NCT03682029 about?
NCT03682029 is a clinical study titled "Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies". The primary purpose of this multi-centre, randomized, placebo-controlled, double-blind phase II study is to investigate if oral vitamin C may change the biology of low-risk myeloid malignancies; i.e., clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndromes (MDS), and...
What is the current status of trial NCT03682029?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 109 participants. The study started on 2017-11-21. Estimated completion is 2025-09-27.
What conditions does trial NCT03682029 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Cytopenia, Chronic Myelomonocytic Leukemia-1.
What interventions are being tested in trial NCT03682029?
The interventions under investigation include: Placebo (OTHER), Vitamin C (ascorbic acid) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03682029?
This trial is sponsored by Rigshospitalet, Denmark, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03682029 being conducted?
This trial has 5 study locations across California, N/A = Not Applicable. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03682029's enrollment target sits among peer trials
109 51st of 173 higher than 123 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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