Vitamin D Status in Patients With Severe Sepsis
Withdrawn before enrolling · Phase 3 · Has a placebo group
Conditions studied: Sepsis, Severe Sepsis, End Organ Damage, Multi Organ Failure
In brief
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.
Key facts
- Study ID
- NCT02684487
- Run by
- Massachusetts General Hospital
- People needed
- 0
- Starts
- 2017-12-01
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2021-05-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 to <80 years
- Admitted to 1 of 4 participating ICUs
- Meet criteria for new-onset severe sepsis* within past 12 hours
You may not qualify if…
- 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)
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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