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Vitamin
High-Dose Vitamin C for Myelodysplastic Syndrome
Phase 1 & 2
Waitlist Available
Led By Mohammad M Abdul Hay, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Study Summary
This trial is testing if high doses of Vitamin C are safe and help patients with myelodysplastic syndrome who have a TET2 mutation.
Who is the study for?
This trial is for adults with Myelodysplastic Syndrome at intermediate or high risk, who have TET2 mutations. They must have adequate liver and kidney function, a certain level of blood cells, and be able to consent. Pregnant women can't join; neither can those with recent cancers (except some skin/breast/cervical), severe infections, major surgery within 2 weeks, HIV/Hepatitis B/C, poor lung function or heart issues.Check my eligibility
What is being tested?
The study tests high-dose Vitamin C infusion therapy's safety and effects on bone marrow/blood in patients with specific genetic changes in their MDS. It's an early-phase trial where everyone gets the same treatment: Vitamin C infusions for five days every four weeks.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to high vitamin doses, possible increased risk of kidney stones for those predisposed to them because Vitamin C can increase oxalate levels in urine which might lead to stone formation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients Who Experienced a Dose Limiting Toxicity (DLT)
Side effects data
From 2018 Phase 2 trial • 20 Patients • NCT0314823610%
Pericarditis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin C
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Group I: Vitamin C 75 gExperimental Treatment1 Intervention
Patients will receive Vitamin C as a continuous intravenous infusion (CIVI) of 75 grams (g) daily over 24 hours for 5 days for total of 375 grams over 5 days.
Group II: Vitamin C 50 gExperimental Treatment1 Intervention
Patients will receive Vitamin C as a continuous intravenous infusion (CIVI) of 50 grams (g) daily over 24 hours for 5 days for total of 250 grams over 5 days up.
Group III: Vitamin C 100 gExperimental Treatment1 Intervention
Patients will receive Vitamin C as a continuous intravenous infusion (CIVI) of 100 grams (g) daily over 24 hours for 5 days for total of 500 grams over 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin C
2017
Completed Phase 4
~18470
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,717 Total Patients Enrolled
Perlmutter Cancer CenterUNKNOWN
Mohammad M Abdul Hay, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not received any cancer treatment for the past two weeks, except for supportive care measures.You have a past medical history of G6PD deficiency, hereditary spherocytosis, or hemochromatosis.You have severe heart problems, such as unstable angina or congestive heart failure, that are not well controlled. You have had a heart attack or stroke within the past 6 months. You also have significant and uncontrolled irregular heartbeats.You have a history of kidney stones or other kidney problems.You have a serious illness that is not under control.If you are already taking hypomethylating agents, you can still join the study and receive vitamin C treatment at the same time.You are currently taking or have previously taken certain medications that stimulate the production of red blood cells or white blood cells.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin C 75 g
- Group 2: Vitamin C 100 g
- Group 3: Vitamin C 50 g
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any openings available for the clinical trial participants?
"Affirmative. Clinicaltrials.gov conveys that this clinical trial is actively enrolling patients, with the initial post being dated to May 1st 2018 and most recent update occurring on July 6th 2022. 18 individuals need to be recruited from 2 medical sites for successful completion of the study."
Answered by AI
What is the intake capacity for this research endeavor?
"Affirmative. Data found on clinicaltrials.gov verifies that this medical research, which was posted on May 1st 2018, is actively looking for patients to enrol in the trial. This endeavor requires 18 people be admitted at two centres of care."
Answered by AI
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