Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Status and phase
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Details and patient eligibility
About
Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- age ≥ 18
- Severe sepsis or septic shock
- Central venous catheter (for blood drawing)
Exclusion criteria
- Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours
- Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses >1,000 I.U. per day or activated vitamin D at any dose
- History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis
- Expected to die or leave the ICU within 48 hours
- History of hypersensitivity or any allergic reaction to calcitriol
- End stage renal disease
- Acute Kidney Injury receiving intermittent renal replacement therapy
- Enrolled in a competing study
- Pregnancy
Trial design
Primary purpose
Allocation
Interventional model
Masking
67 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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