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Study on the Effects of High-Dose Vitamin C in Patients with Severe Burns

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of high-dose vitamin C in patients who have suffered from severe burns. Severe burns are injuries that damage the skin and can affect a large part of the body, often requiring special medical care such as skin grafting. The treatment being tested involves giving patients ascorbic acid, which is another name for vitamin C, through an injection into the veins. This is done in addition to the usual care that patients receive for their burns.

The purpose of the study is to understand how high doses of vitamin C might help improve the recovery of patients with severe burns. The study will compare the effects of vitamin C with a placebo, which is a substance with no active medication, to see if there is a difference in outcomes. The main focus is on whether vitamin C can help reduce the need for organ support, such as machines that help with breathing or medications that support heart function, and whether it can lower the risk of death within 28 days after the injury.

Participants in the study will receive vitamin C every six hours for a total of 96 hours. The study will monitor their progress over a period of 28 days to see how quickly they can be discharged from the hospital and how well they recover without needing additional organ support. The trial aims to provide valuable insights into the potential benefits of vitamin C for patients with severe burns, which could lead to improved treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be assessed to ensure you meet the criteria for participation. This includes being 18 years or older, having deep second and/or third-degree burns, requiring skin grafting, and having burns covering at least 20% of your body surface area.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted by the attending physician to confirm the extent of your burns and your eligibility for the trial. This assessment may be confirmed by the attending surgeon if necessary.

  3. Step 3

    Treatment administration

    If eligible, you will receive **intravenous vitamin C** as part of the trial. The dosage will be 50 mg per kilogram of your body weight, administered every 6 hours for a total of 96 hours.

    This treatment is in addition to the standard care you will receive for your burns.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. The primary focus will be on the composite outcome of persistent organ dysfunction and all-cause mortality over a 28-day period.

    Secondary outcomes include the time to discharge alive from the hospital and the number of days without organ support in the first 28 days.

  5. Step 5

    Completion of trial

    At the end of the 28-day period, your participation in the trial will conclude. The results will contribute to understanding the effects of high-dose vitamin C in patients with severe burns.

Who can join the trial?

5 criteria

  • Must be 18 years of age or older.
  • Must have deep 2nd and/or 3rd degree burns. These are serious burns that affect deeper layers of the skin.
  • Must be assessed as needing skin grafting. This is a procedure where skin is transplanted to cover the burn area.
  • Must have a burn size of at least 20% of the Total Body Surface Area (TBSA). This means the burns cover at least 20% of the body.
  • Both male and female patients can participate.

Who cannot join the trial?

5 criteria

  • Patients who are not severely burned cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate.
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Investigated drugs

Vitamin C is being tested in this trial to see if it can help people with severe burn injuries. The researchers want to find out if giving high doses of Vitamin C through an IV (which means directly into the bloodstream) can improve the chances of recovery. They are looking at whether it can help reduce problems with organs and lower the risk of death within 28 days after the injury. Vitamin C is known for its role in healing and boosting the immune system, and this study is exploring its potential benefits in a critical care setting.

What is already known about the treatment

Vitamin C – This medication is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its potential benefits in treating patients with severe burn injuries. The main therapeutic indication is to help improve outcomes in these patients by reducing organ dysfunction and mortality. At the molecular level, Vitamin C acts as an antioxidant, helping to protect cells from damage and supporting the body's healing processes. It is classified pharmacologically as a vitamin and antioxidant.

Investigated diseases

Severe Burn Injury – Severe burn injury involves damage to the skin and underlying tissues caused by heat, chemicals, electricity, or radiation. The progression of this condition includes an initial inflammatory response, which can lead to fluid loss, infection, and tissue damage. As the body responds to the injury, there may be swelling, blistering, and peeling of the skin. In severe cases, the damage can extend to muscles and bones, leading to complications such as shock and organ dysfunction. The healing process involves the formation of scar tissue, which can result in long-term physical and functional impairments. Recovery can be prolonged and may require extensive medical care and rehabilitation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504772-21-00Protocol code19-211Estimated enrolment373 patientsSponsorQueen's University

sourced from the EU Clinical Trials Register and site verification

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