Thiamine supplementation in the management of diabetic ketoacidosis: An open-label, randomized controlled trial

Diabetic ketoacidosis (DKA) is an acute complication of diabetes mellitus with significant mortality. Emerging evidence suggests a potential role for thiamine, as an adjuvant therapy in DKA management. This study explored the effect of thiamine supplementation on the resolution of DKA. An open-label, randomized controlled trial was conducted at a tertiary care facility. Sixty adult DKA patients were randomized into two groups, using online randomization generator. Thirty patients (intervention group) received thiamine supplementation with standard DKA therapy, and thirty patients (active control group) received only standard DKA therapy. Baseline investigations were performed and statistical analyses were conducted to compare time to resolution of ketoacidosis, morbidity, mortality, and adverse events between the two groups. The study showed no significant difference between the demographic, clinical and laboratory parameters within the two groups. In the intervention vs the active control group, time to resolution of DKA (9.6 vs. 9.9 h, p = 0.342), duration of hospital stays (4.2 vs. 3.7 days, p = 0.157), and complications (20 % vs. 10 %, p = 0.472) showed no significant statistical differences. Infections (41.7 %) and non-compliance (38.3 %) were leading causes for precipitation of DKA. No adverse events were observed. There was no statistically significant difference between the two study groups. Given the safety profile, easy availability and cost effectiveness of thiamine, further research is warranted in larger cohorts to validate the potential therapeutic role of thiamine as adjuvant in DKA management. • The time to resolution of DKA was similar between the two groups. • The mean was 9.6 h for cases and 9.9 h for controls. • Mean hospital stay was 4.2 and 3.7 days for case and control group respectively. • The most prevalent cause for precipitation of DKA was infection (41.7 %). • No adverse event due to thiamine was recorded.