Horgas

Researchers are evaluating the effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients, focusing especially on those with severe vitamin D deficiency. Previous studies, including the VITdAL-ICU trial, showed no overall benefit for hospital length of stay but suggested a significant mortality reduction in patients with severe vitamin D deficiency. This phase III multicenter, placebo-controlled, double-blind randomized trial aims to confirm these findings in a larger group of critically ill adults. Participants will be randomly assigned to receive either a high dose of vitamin D3 or a placebo. The vitamin D3 group will receive a loading dose of 540,000 IU dissolved in 37.5 ml of medium chain triglycerides, followed by daily doses of 4000 IU (10 drops) for 90 days. The placebo group will receive an identical regimen without the vitamin D3. The study includes an interim analysis after half of the planned 1200 patients have completed 28 days. During the study, participants will be monitored for 28-day mortality as the primary outcome. The study will collect data on safety and health status over the 90-day treatment period. Researchers will track adherence to the daily dosing and monitor participants throughout their ICU stay and follow-up. This trial could provide important evidence about the use of vitamin D3 in severely deficient critically ill patients.