A phase 3 randomized, double-blind, placebo-controlled trial evaluated high-dose IV vitamin C (50 mg/kg q6h for 96 hours) vs. placebo in 238 adults with severe burns (≥20% TBSA, deep 2nd/3rd degree requiring grafting) across 24 international burn centers over ~5 years.
The primary composite outcome (28-day mortality + persistent organ dysfunction) occurred in **40.8% of vitamin C** vs. **29.7% of placebo** patients (adjusted RR 1.28, 95% CI 0.99–1.65; P=.06), crossing the futility/harm threshold and triggering early termination. 28-day mortality was significantly higher with vitamin C (15.0% vs. 7.6%; adjusted RR 1.96, 95% CI 1.32–2.90; P=.001), as was hospital mortality (23.3% vs. 16.1%; adjusted RR 1.44; P=.03).
- Trial stopped early at first interim analysis; final sample (n=238) was smaller than planned, limiting precision. - Full-text data on subgroups, mechanism of harm, and covariate details were not available from the abstract alone. - Generalizability may be limited to centers with specialized burn care (24 referral centers across multiple continents).
High-dose IV vitamin C should **not** be used in severe burn injury — it did not reduce organ dysfunction and was associated with nearly double the 28-day mortality compared to placebo. Clinicians should discontinue this practice and avoid adopting it based on prior lower-quality evidence.
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