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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 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.

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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.

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

FieldValue
Enrollment Target 109 participants
Start Date 2017-11-21
Est. Completion 2025-09-27
Phase NA

Sponsor

Rigshospitalet, Denmark

4 total trials

What the Registry Record Tells You About NCT03682029

The ClinicalTrials.gov registry entry for NCT03682029 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (62% lower). The listed sponsor is Rigshospitalet, Denmark, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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