Vitamin C for Myelodysplastic Syndrome
(EVITA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether vitamin C can help manage certain blood disorders by reversing specific genetic changes. The focus includes conditions such as clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndromes (MDS), and early-stage chronic myelomonocytic leukemia (CMML). Participants will take either vitamin C (ascorbic acid) capsules or a placebo daily for a year to determine if vitamin C can improve their condition. This trial suits individuals with persistent low blood cell counts for over six months, diagnosed with these specific conditions, and not currently receiving active treatment for their myeloid malignancy. As an unphased trial, this study offers an opportunity to contribute to groundbreaking research that could lead to new treatment options.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must stop any vitamin C supplements or multivitamins at least 24 hours before the study begins.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that vitamin C is generally safe as a treatment. In one study, patients maintained safe blood levels of vitamin C. Another study examined patients at higher risk for myelodysplastic syndrome and found manageable, non-serious side effects. Although some research has explored high doses of vitamin C, it remains safe overall.
This trial focuses on oral vitamin C. Previous studies suggest that this form is well-tolerated, with no major safety concerns. Participants in those studies took vitamin C without experiencing severe side effects, making it a viable option to consider.12345Why are researchers excited about this trial?
Unlike standard treatments for myelodysplastic syndrome, which often involve medications like azacitidine, decitabine, or lenalidomide, this approach uses vitamin C, a common nutrient. Researchers are excited about vitamin C because it has the potential to work by improving the function of dysfunctional blood cells, which is a different and potentially less toxic mechanism compared to traditional chemotherapy-like treatments. Additionally, vitamin C is taken orally and is usually well-tolerated, making it an attractive option for patients who may struggle with the side effects of conventional therapies.
What evidence suggests that vitamin C might be an effective treatment for myelodysplastic syndrome?
This trial will compare Vitamin C with a placebo to evaluate its effects on myelodysplastic syndrome (MDS). Studies have shown that vitamin C can influence MDS by altering the behavior of affected cells. Research suggests that vitamin C may slow the growth and survival of MDS cells by inducing cell death and influencing DNA changes. In lab studies, vitamin C stopped the growth of certain leukemia cells. Its ability to alter gene function suggests it might reverse some changes seen in these blood disorders. These findings indicate that vitamin C could be a promising treatment option worth further exploration.12356
Who Is on the Research Team?
Kirsten Grønbæk, Professor
Principal Investigator
Rigshospitalet, Denmark
Are You a Good Fit for This Trial?
This trial is for adults with certain low-risk blood disorders like CCUS, MDS, or CMML-0/1. They must have specific types of low blood counts and genetic markers without other causes for their condition. People can't join if they've had recent chemo, are on active treatment (except some supportive care), are allergic to vitamin C, or can't follow the study rules.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either vitamin C or placebo for 12 months to assess changes in epigenetic markers and disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Vitamin C (ascorbic acid)
Trial Overview
The study tests if oral vitamin C can reverse epigenetic changes in patients with low-risk myeloid malignancies. Participants will be randomly given either vitamin C or a placebo without knowing which one they're getting to see if it should be added to standard treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rigshospitalet, Denmark
Lead Sponsor
Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team
Collaborator
University of Southern California
Collaborator
Imperial College London
Collaborator
University of Copenhagen
Collaborator
Odense University Hospital
Collaborator
Technical University of Denmark
Collaborator
Aalborg University Hospital
Collaborator
Van Andel Research Institute
Collaborator
Published Research Related to This Trial
Citations
NCT03433781 | A Phase Ib Study Evaluating the Safety ...
The primary objectives phase 1 study is to establish safety and confirm a steady level of Vitamin C on ≥1 mM in > 75% of the patients is achieved. All patients ...
Ascorbic Acid in Treating Patients with Intermediate or High ...
This phase Ib trial studies the side effects of ascorbic acid and to see how well it works in treating patients with intermediate or high risk myelodysplastic ...
The Effects of High Concentrations of Vitamin C on Cancer ...
Vitamin C at concentrations of 0.25–1.0 mM induced a dose- and time-dependent inhibition of proliferation in acute myeloid leukemia (AML) cell lines.
High-Dose Vitamin C for Myelodysplastic Syndrome
Research suggests that Vitamin C can decrease the growth and survival of myelodysplastic syndrome cells by inducing cell death and affecting DNA changes, which ...
High Dose IV Vitamin C For Myelodysplastic Syndrome
This natural remedy has shown the ability to selectively kill cancer cells associated with MDS while sparing normal cells.
Clinical efficacy and safety of oral and intravenous vitamin ...
Oral intake of vitamin C does not appear to have any effect in patients with malignancies. Data are heterogeneous for intravenous administration.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.