CompletedPhase 2

Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

United States67 participantsStarted 2013-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours

Timeframe: 48 hours

Trial details

NCT IDNCT01689441

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2014-10-27