Vitamin C for Thermal Burns

(VICToRY Trial)

Not currently recruiting at 44 trial locations

Overseen By Maureen Dansereau

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital

Must not be taking: High-dose vitamin C, Hydroxycobalamin

Disqualifiers: Pregnancy, G6PD deficiency, Kidney stones, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether high-dose intravenous vitamin C (ascorbic acid) can help people with severe burns recover faster and with fewer complications. All participants will receive standard burn care; some will also receive vitamin C through an IV, while others will receive a placebo (inactive control). The trial aims to determine if vitamin C reduces organ problems and boosts survival chances. Individuals with deep burns covering at least 20% of their body who require skin grafts might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-dose vitamin C administered through an IV is generally safe for burn patients. One study found that vitamin C did not increase the risk of kidney problems, indicating a positive safety profile. Another study reported no serious side effects from vitamin C in individuals with severe burns. Additionally, vitamin C appeared to reduce the amount of fluids needed for treatment and even lowered death rates when used correctly. Overall, past research suggests that high-dose vitamin C is well-tolerated by people with severe burns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for thermal burns, which often focus on wound care and infection prevention, using vitamin C intravenously offers a unique approach. This treatment works by potentially reducing inflammation and oxidative stress, which can accelerate healing and improve outcomes. Researchers are excited because vitamin C, as an antioxidant, may enhance recovery by strengthening blood vessels and improving immune function, which isn't typically addressed by conventional therapies. Additionally, the intravenous delivery ensures rapid absorption, offering quicker potential benefits compared to oral supplements.

What evidence suggests that high dose intravenous vitamin C might be an effective treatment for thermal burns?

Research has shown that high-dose vitamin C administered through an IV can aid patients with severe burns. Studies have found that it increases survival rates, allowing more patients to live after treatment. It also reduces the amount of fluid needed to stabilize a patient. Additionally, vitamin C helps manage the body's fluid levels, which is crucial for treating burn injuries. In this trial, participants will receive either vitamin C or a placebo to evaluate its effectiveness in improving recovery and survival for those with thermal burns. ^{1 3 4 5 6}

Who Is on the Research Team?

Daren K Heyland, MD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ascorbic Acid
• placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Vitamin C Experimental Treatment 1 Intervention

Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours

Group II: Control group Placebo Group 1 Intervention

Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.

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+

Published Research Related to This Trial

High-dose ascorbic acid therapy (66 mg/kg per hour) significantly reduced the amount of fluid needed for resuscitation in severely burned patients, with the ascorbic acid group requiring only 3.0 mL/kg per percentage of burn area compared to 5.5 mL/kg in the control group.

Patients receiving ascorbic acid experienced less weight gain from fluid retention and had improved respiratory function, with a shorter duration of mechanical ventilation (12.1 days vs. 21.3 days in the control group), indicating its potential efficacy in managing postburn complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Tanaka, H., Matsuda, T., Miyagantani, Y., et al.[2022]

High-dose vitamin C therapy (340 mg/kg/day) significantly reduced water content in burned skin and improved cardiac output compared to control groups in guinea pigs with severe burns, indicating its potential efficacy in burn treatment.

The study demonstrated that high-dose vitamin C allowed for a reduction in resuscitation fluid volume from 4 ml/kg/%burn to 1 ml/kg/%burn while maintaining similar cardiac output, suggesting a safer and more effective resuscitation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced fluid volume requirement for resuscitation of third-degree burns with high-dose vitamin C. Matsuda, T., Tanaka, H., Williams, S., et al.[2019]

In a study involving guinea pigs with severe burns, delayed initiation of high-dose vitamin C therapy significantly reduced the required fluid resuscitation volume to 32.5% of the standard Parkland formula while maintaining adequate cardiac output.

The vitamin C group exhibited lower hematocrit levels and higher cardiac output compared to the control group, indicating that vitamin C may help improve hemodynamic stability after burn injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced resuscitation fluid volume for second-degree burns with delayed initiation of ascorbic acid therapy. Tanaka, H., Matsuda, H., Shimazaki, S., et al.[2019]

Delayed initiation of high-dose vitamin C therapy (starting 6 hours postburn) significantly reduced edema in burned tissue while maintaining stable heart rates and blood pressures in guinea pigs with severe burns.

The vitamin C treatment led to lower hematocrit levels and higher cardiac outputs compared to the control group, indicating improved fluid management and hemodynamic stability after severe thermal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced resuscitation fluid volume for second-degree experimental burns with delayed initiation of vitamin C therapy (beginning 6 h after injury). Sakurai, M., Tanaka, H., Matsuda, T., et al.[2018]

In a study involving 36 guinea pigs with burn injuries, those receiving high doses of vitamin C (375 mg/kg/day) showed a significant increase in body weight recovery, reaching 102% of their preburn weight by day 12, compared to other groups.

Despite the improved weight gain, there was no difference in infection clearance from Staph. aureus among the groups, indicating that while high vitamin C may aid in metabolic recovery, it does not enhance resistance to infection post-burn.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic and immune effects of enteral ascorbic acid after burn trauma. Nelson, JL., Alexander, JW., Jacobs, PA., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-dose vitamin C therapy on severe burn patients: a nationwide cohort study. Nakajima, M., Kojiro, M., Aso, S., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards evidence based emergency medicine: Best BETs from the Manchester Royal Infirmary. BET 3: Vitamin C in severe burns. Ghanayem, H.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900725000462

Intravenous vitamin C in critically ill adult patients with burns Vitamin C levels after burn injury decrease below 50% of average values immediately after thermal injury, reaching deficient levels. · Vitamin C is a scavenger ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6909452/

Effect of high-dose vitamin C therapy on severe burn patients High-dose vitamin C therapy was associated with reduced mortality in patients with severe burns when used under a minimum threshold of 10 g within the first 2 ...

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/390538

Reduction of Resuscitation Fluid Volumes in Severely ... Conclusions Adjuvant administration of high-dose ascorbic acid during the first 24 hours after thermal injury significantly reduces resuscitation fluid volume ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04138394

Study Details | NCT04138394 | VItamin C in Thermal injuRY This study will be the first large international multi-centre trial examining the effects of high dose intravenous vitamin C in burn patients. It represents a ...

5. esmed.org esmed.org/high-dose-vitamin-c-in-septic-burn-patients-outcomes/

High-Dose Vitamin C in Septic Burn Patients: Outcomes Administration of vitamin C reduced fluid balance at day 3 (2 ml/weight/day for G1 vs 13 ml/weight/ day for G2; p= 0,008), reduced significantly doses of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21131846/

Resuscitation after severe burn injury using high-dose ... Although this study did not find a difference in outcomes with VC administration, it demonstrates that VC can be safely used without an increased risk of renal ...