CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
100,000 IU cholecalciferol +1 moredrug
Likely dose
100,000 IU cholecalciferolfrom 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/NCT01689779
NCT01689779Phase 3Completed
CompareCT.gov

Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients

Massachusetts General Hospital·interventional·Posted Sep 21, 2012·Updated Sep 28, 2017

In Brief

A Phase 3 clinical trial evaluating 100,000 IU cholecalciferol and Placebo for Hypovitaminosis D. Completed, enrolled 60 participants across 1 site.

Detailed Summary

A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of surgical site infections (SSIs). At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems. The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypovitaminosis D
CountriesUnited States
CollaboratorsBio-Tech Pharmacal, Inc.

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartJan 1, 2013
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.8 years ago

Interventions

100,000 IU cholecalciferoldrug

active drug

Placebodrug

comparator drug