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Eligibility
for people ages 18 years and up
Location
at Fresno, California and other locations
Dates
study started
estimated completion:

Description

Summary

This study aims to evaluate the effect of early administration of high-dose vitamin D3 in reducing all-cause, all-location mortality in vitamin D deficient patients at high risk for ARDS. Patients will be screened for vitamin D deficiency (<20 ng/mL). Only patients screened as vitamin D deficient will be randomized. 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.

Details

Primary Objective:

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.

Primary Hypothesis:

Early administration of vitamin D3 (cholecalciferol) will improve all-cause, all-location mortality to day 90 in vitamin D deficient patients at high risk for ARDS and mortality.

Patients will be recruited from the EDs, hospital wards, operating rooms, ICUs and other acute care areas of the PETAL Network Clinical Centers. Screening will include a test for Vitamin D (25OHD) levels using either the hospital's clinical laboratory or an FDA-approved point-of-care device (FastPack IP, Qualigen Inc). Patients screened as vitamin D deficient (<20 ng/mL) will be randomized. Half of the randomized patients will receive an early administration of high-dose vitamin D3 and the other half will receive a placebo (orally or via naso/orogastric tube).

Vitamin D has pleiotropic roles in regulating immune function and maintaining epithelial surface integrity. Strong preclinical data support the protective role of vitamin D in regulating pulmonary inflammation and disruption of the alveolar-capillary membrane that are fundamental to ARDS pathogenesis.

Keywords

Acute Respiratory Distress Syndrome Vitamin D Deficiency Critical Illness ARDS Vitamin D Vitamins Ergocalciferols Cholecalciferol

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥ 18 years
  2. Intention to admit to ICU from emergency department, hospital ward, operating room,or outside facility
  3. One or more of the following acute risk factors for ARDS and mortality contributing directly to the need for ICU admission:

    Pulmonary

  4. Pneumonia
  5. Aspiration
  6. Smoke Inhalation
  7. Lung contusion
  8. Mechanical ventilation for acute hypoxemic or hypercarbic respiratory failure Extra-Pulmonary
  9. Shock
  10. Sepsis
  11. Pancreatitis
  12. Vitamin D deficiency (screening 25OHD level <20 ng/mL)

You CAN'T join if...

  1. Inability to obtain informed consent
  2. Unable to randomize within 12 hours of ICU admission decision
  3. Unable to take study medication by mouth or enteral tube
  4. Baseline serum calcium>10.2 mg/dL (2.54 mmol/L) or ionized calcium>5.2 mg/dL (1.30 mmol/L)
  5. Known kidney stone in past year or history of multiple (>1) prior kidney stone episodes
  6. Decision to withhold or withdraw life-sustaining treatment (patients are still eligible if they are committed to full support except cardiopulmonary resuscitation if a cardiac arrest occurs)
  7. Expect <48 hour survival
  8. If no other risk factors present, a) mechanical ventilation primarily for airway protection, pain/agitation control, or procedure; or b) elective surgical patients with routine postoperative mechanical ventilation; or c) anticipated mechanical ventilation duration <24 hours; or d) chronic/home mechanical ventilation for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).
  9. Prisoner
  10. Pregnancy

Locations

  • Stanford University not yet accepting patients
    Stanford, California, 94305, United States
  • UC Davis Medical Center not yet accepting patients
    Sacramento, California, 95817, United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts General Hospital
Links
Website for the PETAL Network
ID
NCT03096314
Phase
Phase 3
Study Type
Interventional
Last Updated
October 1, 2016
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