At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Intended ICU admission from ED, hospital ward, OR, or outside facility
- ✓One or more acute risk factors for ARDS and mortality: pneumonia, aspiration, smoke inhalation, lung contusion, acute hypoxemic/hypercarbic respiratory failure, shock, sepsis, or pancreatitis
- ✓Vitamin D deficiency defined as 25OHD <20 ng/mL
- ✕Baseline serum calcium >10.2 mg/dL or ionized calcium >5.2 mg/dL
- ✕Known kidney stone in past year or history of >1 prior kidney stone episodes
- ✕Expected survival <48 hours
- ✕Mechanical ventilation for airway protection only, pain/agitation control, routine postoperative use, anticipated duration <24 hours, or chronic/home mechanical ventilation (non-invasive ventilation for sleep-disordered breathing is allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vitamin D to Improve Outcomes by Leveraging Early Treatment
In Brief
A Phase 3 clinical trial evaluating Vitamin D3 and Placebo for Acute Respiratory Distress Syndrome and 2 related conditions. Completed, enrolled 1,358 participants across 47 sites.
Detailed Summary
Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Patients screened as vitamin D deficient (\<20 ng/mL) were randomized. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality.
Study Details
Timeline
Interventions
540,000 IU vitamin D3 delivered as a single, liquid enteral dose administered either orally or via naso/orogastric tube
A single, liquid enteral dose identical in appearance and consistency to cholecalciferol administered either orally or via naso/orogastric tube.