CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Calcitriol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01689441
NCT01689441Phase 2Completed

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

Brigham and Women's Hospital·interventional·Posted Sep 21, 2012·Updated Nov 10, 2020

In Brief

A Phase 2 clinical trial evaluating Calcitriol and Placebo for Severe Sepsis or Septic Shock. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartFeb 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.8 years ago

Interventions

Calcitrioldrug

Placebodrug