Vitamin D to Improve Outcomes by Leveraging Early Treatment

• Status: Completed
• Trial end date: 2018-12-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

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

1. Pneumonia

2. Aspiration

3. Smoke Inhalation

4. Lung contusion

5. Mechanical ventilation for acute hypoxemic or hypercarbic respiratory failure Extra-Pulmonary

6. Shock

7. Sepsis

8. Pancreatitis

4. Vitamin D deficiency (screening 25OHD level <20 ng/mL)

Exclusion Criteria:

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