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Dietary Supplement
Vitamin C for Myelodysplastic Syndrome (EVITA Trial)
N/A
Waitlist Available
Led By Kirsten Grønbæk, Professor
Research Sponsored by Rigshospitalet, Denmark
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A diagnosis of CMML-0 or -1 as according to WHO 2016 diagnostic criteria AND The presence of a detectable mutation in genes recurrently affected in myeloid malignancy representing a clonal marker (excluding germline mutations)
A diagnosis of MDS as according to World Health Organization (WHO) 2016 diagnostic criteria • Revised international prognostic scoring system (IPSS-R) risk score ≤ 3 AND bone marrow blast percentage < 5 defining low-risk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at 3 months
Awards & highlights
EVITA Trial Summary
This trial is testing whether oral vitamin C supplements can change the biology of low-risk myeloid malignancies by reversing characteristic epigenetic changes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Vitamin C is generally safe but may cause side effects like stomach upset, heartburn, nausea, and diarrhea. Allergic reactions could occur in rare cases.
EVITA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have CMML-0 or -1 with a specific gene mutation linked to my cancer.
Select...
My MDS is low-risk with a bone marrow blast percentage under 5.
EVITA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and at 3 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at 3 months and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median Change from Baseline in Variant Allele Frequency at 12 Months
Secondary outcome measures
Change in intestinal permeability and gut microbiota
Mean Change from Baseline in 5-hmC/5-mC Level at 3 Months and 12 months
Mean Change from Baseline in 5-mC at Selected Sites at 12 Months
+6 moreEVITA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin CExperimental Treatment1 Intervention
Vitamin C (ascorbic acid) 500 mg/capsule. Ingestion of 2 capsules (1000 mg) daily for 12 months.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin C (ascorbic acid)
2010
Completed Phase 3
~520
Find a Location
Who is running the clinical trial?
Van Andel Institute - Stand Up To Cancer Epigenetics Dream TeamUNKNOWN
1 Previous Clinical Trials
196 Total Patients Enrolled
University of Southern CaliforniaOTHER
906 Previous Clinical Trials
1,595,940 Total Patients Enrolled
Imperial College LondonOTHER
997 Previous Clinical Trials
14,910,980 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have low blood counts for more than 6 months, not caused by common conditions or other cancers.I have CMML-0 or -1 with a specific gene mutation linked to my cancer.I am willing to stop taking vitamin C and multivitamins 24 hours before tests.I have not had chemotherapy in the last 6 months.I understand the trial information and am willing to sign the consent form.I am currently being treated for my blood cancer, but not with G-CSF or erythropoietin.You have had an allergic reaction to ascorbic acid in the past.My MDS is low-risk with a bone marrow blast percentage under 5.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin C
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there capacity left for participants in this clinical trial?
"According to the clinicaltrials.gov directory, this medical trial is not currently enrolling participants; however, it was initially posted on November 21st 2017 and last edited October 24th 2022. There are presently 448 other trials which are accepting volunteers at this time."
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