NCT01689441

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Sepsis or Septic Shock

Interventions

Type	Name	Description
DRUG	Calcitriol
DRUG	Placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-09-21
• Last updated: 2020-11-10
• Results posted: 2014-10-30

Locations

1 site across 1 country: United States