Vitamin D to Improve Outcomes by Leveraging Early Treatment
Status:
Completed
Trial end date:
2018-12-11
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins