Vitamin D to Improve Outcomes by Leveraging Early Treatment

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome, Vitamin D Deficiency, Critical Illness

In brief

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.

Key facts

Study ID

NCT03096314

Run by

Massachusetts General Hospital

People needed

1358

Starts

2017-04-27

Expected to finish

2018-12-11

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Pulmonary
• Pneumonia
• Aspiration
• Smoke Inhalation
• Lung contusion
• Mechanical ventilation for acute hypoxemic or hypercarbic respiratory failure Extra-Pulmonary
• Shock
• Sepsis
• Pancreatitis
• Vitamin D deficiency (screening 25OHD level <20 ng/mL)

You may not qualify 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
• Baseline serum calcium >10.2 mg/dL (2.54 mmol/L) or ionized calcium >5.2 mg/dL (1.30 mmol/L)
• 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).
• Prisoner
• Pregnancy

Where it is running

• UCSF Fresno — Fresno, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Medical Center of Aurora — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• St. Joseph Hospital — Del Norte, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• University Medical Center — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• St. Vincent's Hospital — Worcester, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mt. Sinai Hospital — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.