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

Launched by MEDICAL UNIVERSITY OF GRAZ · Jun 13, 2017

Keywords

ClinConnect Summary

The VITDALIZE Study is researching whether high doses of vitamin D3 can help improve survival rates in critically ill adult patients, particularly those who have low levels of vitamin D. The study found that while high-dose vitamin D did not shorten the hospital stay for everyone, it significantly reduced the risk of death within 28 days for patients with severe vitamin D deficiency. This means that for these patients, taking vitamin D3 might be a simple and cost-effective way to potentially improve their chances of survival.

To participate in this study, you need to be at least 18 years old and expected to stay in the Intensive Care Unit (ICU) for at least 48 hours. You should also have very low levels of vitamin D in your blood. If you join the study, you will receive either high-dose vitamin D3 or a placebo (a substance with no active medicine) during your ICU stay. This trial is important because it could lead to a new treatment that may be widely used to help critically ill patients around the world, especially those suffering from vitamin D deficiency.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥18 years
• • Anticipated ICU stay ≥ 48 hours
• • Admission to ICU ≤ 72 hours before screening
• • Severe vitamin D deficiency (≤12 ng/ml or undetectable)
• Exclusion Criteria:
• • Severe gastrointestinal dysfunction (\> 400 ml residual volume)/unable to take study medication
• • Do not resuscitate (DNR) order/imminent death
• • hypercalcemia
• • known recent nephrolithiasis, active tuberculosis or sarcoidosis
• • pregnancy/lactation
• • not deemed appropriate by study team/physician