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Vitamin C for Thermal Burns (VICToRY Trial)

Phase 3
Recruiting
Led By Daren K Heyland, MD
Research Sponsored by Clinical Evaluation Research Unit at Kingston General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Minimum burn size of ≥ 20% Total Body Surface Area (TBSA)
Must not have
Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Concomitant use of hydroxycobalamin (vitamin B12) for suspected cyanide poisoning.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial

Summary

This trial will test whether high doses of vitamin C can improve outcomes for burn patients.

Who is the study for?
Adults with severe burns covering at least 20% of their body, who need skin grafting, can join this trial. They must be able to start treatment within 24 hours of being admitted to the hospital and not already receiving high-dose IV vitamin C. Pregnant or lactating individuals, those expected not to survive the next 72 hours, with a recent history of kidney stones or certain deficiencies cannot participate.
What is being tested?
The VICToRY Trial is testing if high-dose intravenous vitamin C can help critically ill burn patients recover faster and have better survival rates compared to standard care alone. Half will receive vitamin C along with standard care while the other half gets a placebo alongside standard treatment.
What are the potential side effects?
Potential side effects from high-dose IV vitamin C may include digestive discomfort and an increased risk for kidney stones in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My burns cover 20% or more of my body.
Select...
I have deep burns that need skin grafting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a G6PD deficiency.
Select...
I am taking vitamin B12 for possible cyanide poisoning.
Select...
I am currently taking high-dose vitamin C through an IV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Persistent Organ Dysfunction + Death
Time to discharge alive from hospital
Secondary study objectives
PODS+death
Time to Discharge Alive
Other study objectives
6 month mortality
Duration of mechanical ventilation
Gram negative bacteremia
+6 more

Side effects data

From 2019 Phase 4 trial • 66 Patients • NCT02209636
38%
Non-serious adverse events
3%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lanthanum Carbonate
Placebo
Placebo- Phosphorus Balance Sub-study
Lanthanum Carbonate- Phosphorus Balance Sub-study

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin CExperimental Treatment1 Intervention
Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours
Group II: Control groupPlacebo Group1 Intervention
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ascorbic Acid
2017
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

Clinical Evaluation Research Unit at Kingston General HospitalLead Sponsor
15 Previous Clinical Trials
3,670 Total Patients Enrolled
Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, GermanyUNKNOWN
Daren K Heyland, MDPrincipal InvestigatorQueen's University
10 Previous Clinical Trials
4,607 Total Patients Enrolled

Media Library

Ascorbic Acid Clinical Trial Eligibility Overview. Trial Name: NCT04138394 — Phase 3
Thermal Burns Research Study Groups: Vitamin C, Control group
Thermal Burns Clinical Trial 2023: Ascorbic Acid Highlights & Side Effects. Trial Name: NCT04138394 — Phase 3
Ascorbic Acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04138394 — Phase 3
~210 spots leftby Dec 2026
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