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VIOLET: Vitamin D to Improve Outcomes by Leveraging Early Treatment

Status: 
Active
Period: 
April 2017
NCT Identifier: 
NCT03096314

Purpose: This study will look at the effect of early administration of high-dose vitamin D3 in reducing mortality in patients with low levels of vitamin D who are at high risk for Acute Respiratory Distress Syndrome (ARDS). Patients will be screened for vitamin D deficiency (levels less than 20 ng/mL). Those patients meeting the screening threshold will be randomized into the trial. Half of the vitamin-D deficient patients will be given a high-dose of vitamin D3 and the other half will be given a placebo (like a sugar pill).

Trial Summary:

  • Study Design: Randomized, double-blinded, placebo-controlled, phase III trial of early vitamin D3 in vitamin D deficient patients at high risk for ARDS and mortality.
  • Purpose: To assess the efficacy and safety of early administration of vitamin D3 (cholecalciferol) in reducing mortality and morbidity for vitamin D deficient patients at high risk for ARDS and mortality.
  • Sample Size: The study will randomize up to 3,000 patients from PETAL network hospital emergency departments, ICUs, and general floors.