Phase 2
N=67
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Severe Sepsis or Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT01689441 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours — 76; 82 ng/ml — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Calcitriol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours |
76; 82 | 0.25 |
| SECONDARY Plasma Interleukin-6 (IL-6) Levels at 48 Hours |
41; 32 | 0.51 |
| SECONDARY Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours |
0.6; 0.7 | 0.54 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01689441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.