Vitamin D Status in Patients With Severe Sepsis

• Status: Withdrawn
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Sepsis is a clinical entity that complicates infection. Without early recognition and timely management, it can rapidly progress to severe sepsis, septic shock, and culminate in multiple organ dysfunction syndrome. Forty to 70% of septic patients have low vitamin D status, yet little is known about the impact of vitamin D3 (vitD3) supplementation in this patient population. As such, the investigators propose a randomized, double-blinded, placebo-controlled trial to test the hypothesis that early, rapid correction of low vitamin D status, as an adjunct to established treatment guidelines, will improve clinical outcomes and measurably alter immune profile in patients with severe sepsis.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Age ≥18 to <80 years

• Admitted to 1 of 4 participating ICUs

• Meet criteria for new-onset severe sepsis* within past 12 hours

Exclusion Criteria:

• Age ≥80 years

• Not anticipated to survive ≥48 hours

• Inability to obtain informed consent from patient/suitable proxy within 22 hours of new-onset severe sepsis

• Comfort measures, hospice, or palliative care status

• Documented adverse reaction to vitamin D supplementation

• Inability to tolerate enteral feeds/medications

• Renal stones within past year

• Hypercalcemia within past year

• Baseline serum calcium ≥10.5 mg/dL

• Established diagnosis of medical condition associated with high risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism)