CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Cholecalciferol +1 moredietary
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/NCT01896544
NCT01896544Phase 3Completed

The Effect of Cholecalciferol Supplementation on Vitamin D Status in Sepsis

Massachusetts General Hospital·interventional·Posted Jul 11, 2013·Updated Jun 13, 2016

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

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

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartJan 1, 2014
Primary CompletionAug 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.0 years ago

Interventions

Cholecalciferoldietary

7ml syringe of cholecalciferol suspension given through nasogastric (NG) or orogastric (OG) tube

Placebodietary

7ml syringe of placebo cholecalciferol suspension given through nasogastric (NG) or orogastric (OG) tube