drugset / Trial / NCT01689441

Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

NCT01689441

Phase 2 Completed 67 enrolled Brigham and Women's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.

Timeline

Start
2013-02
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcitriol Small molecule 2 ug Intravenous