Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
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
Outcome
Missed primary endpoint
paper Patients randomized to calcitriol (n = 36) versus placebo (n = 31) had similar plasma cathelicidin protein levels at 24 hours (P = 0.16). PMID 25029202 ↗
paper Calcitriol administration did not increase plasma cathelicidin protein levels in critically ill patients with sepsis PMID 25029202 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcitriol | Small molecule | 2 ug | Intravenous |