Vitamin C (ascorbic acid) 500 mg/capsule. Ingestion of 2 capsules (1000 mg) daily for 12 months.

Placebo capsule. Ingestion of 2 capsules daily for 12 months. Placebo will be prepared as capsules that look and taste identical to the vitamin C supplement capsules. The content of the placebo is lactose, potato starch, gelatin, magnesium stearate, and talc.

Myelodysplastic Syndromes

Chronic Myelomonocytic Leukemia-1

Cytopenia

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

Vitamin C (ascorbic acid)

Placebo

Nordic Council of Ministers (2012). Vitamin C. In Nordic Nutrition Recommendations (NNR) (Copenhagen), pp. 465-473

University of Southern California

Rigshospitalet

Herlev Hospital

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

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

Mean change from baseline to 12 months in mutant allele burden as measured by the variant allele frequency (VAF) and number of mutations.

Mean change from baseline to 3 months in global 5-hmC/5-mC measured in hematopoietic stem cells is compared between the vitamin C group and the placebo group. In addition, the mean change from baseline in 5-hmC/5-mC at 12 months is compared between participants in the vitamin C arm with baseline plasma vitamin C level in the normal range vs. participants in the vitamin C arm with baseline plasma vitamin C level below the normal range.

Mean change from baseline to 12 months in 5-mC at promoters/enhancers/long terminal repeats, and other regulatory genomic regions of tumor suppressors/methylated driver genes/genes involved in hematopoietic development.

Mean change from baseline to 12 months in methylated histone H3 lysine at position 9 at promoters/enhancers/long terminal repeats, and other regulatory regions of tumor suppressors/methylated driver genes/genes involved in hematopoietic development.

Mean change from baseline to 12 months in plasma cytokine levels (e.g., IL-6, S100A9, etc.).

Mean change from baseline to 12 months in mRNA levels of tumor suppressor genes, oncogenes, epigenetic regulators, cytokines, and genes involved in hematopoietic development.

Mean change from baseline to 3 months in mRNA levels of tumor suppressor genes, oncogenes, epigenetic regulators, cytokines, and genes involved in hematopoietic development.

Number of serious adverse events and treatment-related adverse events as assessed by CTCAE v5.0. Adverse events, that are not considered serious or related to vitamin C intake, will not be recorded.

Percentage of participants with baseline plasma vitamin C level below the normal physiological range.

Mean change from baseline to 12 months in global 5-hmC/5-mC measured in hematopoietic stem cells is compared between the vitamin C group and the placebo group. In addition, the mean change from baseline in 5-hmC/5-mC at 12 months is compared between participants in the vitamin C arm with baseline plasma vitamin C level in the normal range vs. participants in the vitamin C arm with baseline plasma vitamin C level below the normal range.

Kirsten Grønbæk

Professor, MD, DMSc

Rigshospitalet, Denmark

Van Andel Research Institute

Imperial College London

University of Copenhagen

Zealand University Hospital

Technical University of Denmark

Prospective, randomized, placebo-controlled trial.

Randomization performed by the independent provider of study medication (Glostrup Pharmacy).

scurvy/diarré

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

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