666 Participants Needed

Vitamin C for Thermal Burns

(VICToRY Trial)

Recruiting at 38 trial locations
MD
Overseen ByMaureen Dansereau
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving high-dose IV vitamin C or using hydroxycobalamin (vitamin B12) for suspected cyanide poisoning, you may not be eligible to participate.

What data supports the effectiveness of the drug Ascorbic Acid for treating thermal burns?

Research suggests that high-dose vitamin C (ascorbic acid) can reduce the amount of fluid needed for resuscitation, improve wound healing, and decrease ventilation needs in patients with severe burns. However, more large-scale studies are needed to confirm these promising results.12345

Is high-dose vitamin C safe for treating burns?

Research on high-dose vitamin C for burn treatment shows it can reduce fluid needs and swelling without causing harm, as no deaths or significant changes in heart rates or blood pressure were observed in studies.13456

How does high-dose vitamin C treatment differ from other treatments for thermal burns?

High-dose vitamin C treatment for thermal burns is unique because it reduces the amount of fluid needed for resuscitation and decreases swelling in burned and unburned tissues. This is different from standard treatments, which typically require larger fluid volumes to manage burn injuries.14678

Research Team

DK

Daren K Heyland, MD

Principal Investigator

Queen's University

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.
My burns cover 20% or more of my body.
I have deep burns that need skin grafting.

Exclusion Criteria

I have been in the hospital for more than 24 hours before giving consent.
Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating
I have a G6PD deficiency.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose intravenous vitamin C or placebo for 96 hours

1 week
Daily visits for administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Long-term follow-up

Participants' health-related quality of life and mortality are assessed

6 months

Treatment Details

Interventions

  • Ascorbic Acid
  • placebo
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Clinical Evaluation Research Unit at Kingston General Hospital

Lead Sponsor

Trials
16
Recruited
4,300+

Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, Germany

Collaborator

Trials
1
Recruited
670+

Findings from Research

In a study of 2713 severe burn patients, high-dose vitamin C (over 10g within 2 days of admission) was linked to a significant reduction in in-hospital mortality, with a risk ratio of 0.79, indicating a 21% lower risk of death compared to those who did not receive it.
However, when the dosage exceeded 24g, there was no significant difference in mortality rates, suggesting that the effectiveness of high-dose vitamin C may depend on the specific dosage used.
Effect of high-dose vitamin C therapy on severe burn patients: a nationwide cohort study.Nakajima, M., Kojiro, M., Aso, S., et al.[2020]
Preliminary evidence from four studies indicates that high-dose vitamin C may reduce fluid requirements for resuscitation in adult burn patients with over 15% total body surface area affected, potentially leading to faster recovery.
Vitamin C supplementation appears to improve wound healing and decrease the need for ventilation in severe burn cases, but more extensive trials are necessary to confirm these findings.
Towards evidence based emergency medicine: Best BETs from the Manchester Royal Infirmary. BET 3: Vitamin C in severe burns.Ghanayem, H.[2018]
In a study involving 54 patients with second-degree burns covering more than 20% of their body, high-dose intravenous ascorbic acid (1250 mg every 6 hours) did not lead to a significant difference in mortality compared to a lower oral dose (500 mg every 6 hours), despite a higher predicted mortality rate in the high-dose group.
The study suggests that high-dose intravenous ascorbic acid may have protective effects during burn resuscitation, potentially improving clinical outcomes, although further research is needed to clarify its efficacy and optimal dosing.
High-dose intravenous versus low-dose oral vitamin C in burn care: potential protective effects in the severely burned: a retrospective cohort study.Malkoc, A., Jong, S., Fine, K., et al.[2023]

References

Effect of high-dose vitamin C therapy on severe burn patients: a nationwide cohort study. [2020]
Towards evidence based emergency medicine: Best BETs from the Manchester Royal Infirmary. BET 3: Vitamin C in severe burns. [2018]
High-dose intravenous versus low-dose oral vitamin C in burn care: potential protective effects in the severely burned: a retrospective cohort study. [2023]
Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. [2022]
Reduced resuscitation fluid volume for second-degree experimental burns with delayed initiation of vitamin C therapy (beginning 6 h after injury). [2018]
Reduced resuscitation fluid volume for second-degree burns with delayed initiation of ascorbic acid therapy. [2019]
Metabolic and immune effects of enteral ascorbic acid after burn trauma. [2019]
Reduced fluid volume requirement for resuscitation of third-degree burns with high-dose vitamin C. [2019]