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ACTIVE NOT RECRUITING
NCT03682029
NA

Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

Official title: Epigenetics, Vitamin C, and Abnormal Hematopoiesis - Role of Vitamin C in Epigenetic Regulation in Hematopoiesis Sub-Study on CCUS, Low-Risk MDS, and CMML-0/1

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

109

Start Date

2017-11-21

Completion Date

2025-09-27

Last Updated

2024-04-17

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Vitamin C (ascorbic acid)

Monotherapy with oral vitamin C supplementation to elevate plasma vitamin C level to the upper end of the physiological range.

OTHER

Placebo

Placebo

Locations (5)

Keck Hospital of University of Southern California

Los Angeles, California, United States

Rigshospitalet

Copenhagen, N/A = Not Applicable, Denmark

Aalborg University Hospital

Aalborg, Denmark

Herlev University Hospital

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark