High-dose Vitamin D3 Treatment to Reduce 28-day Mortality in Severely Vitamin D Deficient Critically Ill Adults A Multicenter Phase 3 Randomized Placebo-controlled Trial

What this Trial Is About

Researchers are investigating the effect of high-dose vitamin D3 on mortality in adult critically ill patients, particularly those with severe vitamin D deficiency. Previous studies found no benefit in hospital length of stay but suggested a significant reduction in 28-day mortality in patients with very low vitamin D levels. This phase III randomized controlled trial aims to confirm these findings in a larger, multicenter setting. Participants will be randomly assigned to receive either a high dose of vitamin D3 or a placebo. The vitamin D3 group will get an oral loading dose of 540,000 IU dissolved in 37.5 ml of medium chain triglycerides MCT, followed by 4000 IU daily 10 drops for 90 days. The placebo group will receive an identical MCT loading dose and daily drops for the same duration. The study features a double-blind design and an interim analysis after half of the planned patients complete 28 days. During the study, participants will be monitored for 28-day mortality as the primary outcome. Secondary outcomes include hospital length of stay, hypercalcemia at day 5, and hospital readmissions within 90 days. The study involves regular assessments, safety monitoring by an independent board, and continued enrollment while interim analyses are conducted. Total participation spans at least 90 days with detailed follow-up.

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients