Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Completed · Phase 2 · Has a placebo group
Conditions studied: Severe Sepsis or Septic Shock
In brief
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.
Key facts
- Study ID
- NCT01689441
- Run by
- Brigham and Women's Hospital
- People needed
- 67
- Starts
- 2013-02-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2020-11-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age ≥ 18
- Severe sepsis or septic shock
- Central venous catheter (for blood drawing)
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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