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VIOLET study

Title Vitamin D to Improve Outcomes by Leveraging Early Treatment
Therapeutic Area Vitamin D Deficiency
Principal Investigator Nicholas Hill, MD
Min Age 18 Years
Gender Any
Contact Karen Visnaw
617 636-1334
kvisnaw@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03096314

Overview

A randomized, double-blinded, placebo-controlled, phase III trial (up to maximum n=3000) of early vitamin D3 in vitamin D deficient patients at high risk of ARDS and mortality

Study Details

Inclusion Criteria

  • Age of 18 years or greater
  • Intention to admit to ICU from emergency department, hospital ward, operating room, or outside facility.
  • Vitamin D deficiency (screening 250HD level < 20ng/mL)

Exclusion Criteria

  • Inability to obtain informed consent
  • Unable to randomize within 12 hours of ICU admission decision
  • Unable to take study medication by mouth or enteral tube

Study Requirements

ICU stay, following patient until Day 90 or discharged from home, 2 blood draws (4 tablespoons)