At a glance
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The Effect of Cholecalciferol Supplementation on Vitamin D Status in Sepsis
In Brief
A Phase 3 clinical trial evaluating Cholecalciferol and Placebo for Hypovitaminosis D. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Sepsis in a clinical entity that occurs in patients with serious infections. Though the severity of illness may vary, every year, approximately 1.6 million Americans are treated for sepsis. Even with timely interventions, anywhere from 16% to \>80% of patients with sepsis will not survive. Immune dysfunction is thought to play a critical role in the ability for infections to evolve into sepsis and to eventually lead to death. Recently, vitamin D has been identified as a key regulator of the immune system. While it remains unclear whether optimizing vitamin D status may improve outcomes in sepsis, little is known about the effects of vitamin D supplementation in patients with severe infections. As such, our goal is to study whether high doses of cholecalciferol (vitamin D3) can improve vitamin D status and boost certain aspects of the immune system in patients with sepsis.
Study Details
Timeline
Interventions
7ml syringe of cholecalciferol suspension given through nasogastric (NG) or orogastric (OG) tube
7ml syringe of placebo cholecalciferol suspension given through nasogastric (NG) or orogastric (OG) tube