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.
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.
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.
Acute Respiratory Distress SyndromeVitamin D DeficiencyCritical IllnessARDSVitamin DVitaminsErgocalciferolsCholecalciferol
You can join if…
Open to people ages 18 years and up
Age ≥ 18 years
Intention to admit to ICU from emergency department, hospital ward, operating room,or outside facility
One or more of the following acute risk factors for ARDS and mortality contributing directly to the need for ICU admission:
Mechanical ventilation for acute hypoxemic or hypercarbic respiratory failure Extra-Pulmonary
Vitamin D deficiency (screening 25OHD level <20 ng/mL)
You CAN'T join if...
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
Known kidney stone in past year or history of multiple (>1) prior kidney stone episodes
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)
Expect <48 hour survival
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).
UCSF Fresnonot yet accepting patients Fresno, California, 93701, United States
UCSF Medical Centernot yet accepting patients San Francisco, California, 94143, United States
Stanford Universitynot yet accepting patients Stanford, California, 94305, United States
UC Davis Medical Centernot yet accepting patients Sacramento, California, 95817, United States
Ronald Reagan UCLA Medical Center Los Angeles, California, 90095, United States