NCT04138394

VItamin C in Thermal injuRY: The VICToRY Trial

VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 666 (estimated)
• Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In certain disease states, such as those associated with severe burns and other critical illnesses, the relationship between nutrient deficiencies, altered immune status, and acquired infection has been recognized for many years. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies, thereby predisposing patients to impaired immune function and increased risk of developing infectious complications, organ dysfunction, and death. We aim to conduct a large-scale, multi-center randomized trial to evaluate the effect of high-dose (50mg/kg every 6 hours for 96 hours) intravenous vitamin C in addition to standard of care (SOC) on 28-days composite outcome of Persistent Organ Dysfunction (POD) and all-cause mortality compared to add-on placebo and SOC. Patients will be allocated to 2 groups, active or control: patients in the active group will receive intravenous vitamin C at 50mg/kg every 6 hrs for 96 hrs. Patients in the control group will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. 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 unique collaboration of burn units worldwide that is coordinated by the Clinical Evaluation Research Unit, based in Kingston Ontario Canada, a coordinating center that has demonstrated the ability to run multi-center trials and translate findings into practice.

Conditions

• Shock
• Thermal Burn

Interventions

Type	Name	Description
DRUG	Ascorbic Acid	Patients will receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours).
DRUG	placebo	Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.

Timeline

• Start date: 2020-07-24
• Primary completion: 2025-12-18
• Completion: 2026-03-31
• First posted: 2019-10-24
• Last updated: 2026-04-06

Locations

33 sites across 9 countries: United States, Belgium, Canada, Costa Rica, Germany, Mexico, Paraguay, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study