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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitriol | Experimental | Calcitriol 2mcg IV x 1 |
|
| Placebo | Placebo Comparator | Normal saline 2cc IV x 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Interleukin-6 (IL-6) Levels at 48 Hours | 48 hours | |
| Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours | NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Leaf, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25029202 | Result | Leaf DE, Raed A, Donnino MW, Ginde AA, Waikar SS. Randomized controlled trial of calcitriol in severe sepsis. Am J Respir Crit Care Med. 2014 Sep 1;190(5):533-41. doi: 10.1164/rccm.201405-0988OC. |
| Label | URL |
|---|---|
| Link to manuscript in pubmed | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcitriol | Calcitriol 2mcg IV x 1 Calcitriol |
| FG001 | Placebo | Normal saline 2cc IV x 1 Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcitriol | Calcitriol 2mcg IV x 1 Calcitriol |
| BG001 | Placebo | Normal saline 2cc IV x 1 Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours | Posted | Median | Inter-Quartile Range | ng/ml | 48 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcitriol | Calcitriol 2mcg IV x 1 Calcitriol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Leaf, MD, MMSc | Brigham and Women's Hospital | 617-732-5500 | deleaf@partners.org |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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|
| 48 hours |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Plasma Interleukin-6 (IL-6) Levels at 48 Hours | Posted | Median | Inter-Quartile Range | pg/ml | 48 hours |
|
|
|
|
| Secondary | Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours | NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations. | The discrepancy in "number of participants analyzed" for this outcome vs. other outcomes is due to urine samples not being available in all participants | Posted | Median | Inter-Quartile Range | mg/mg | 48 hours |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo | Normal saline 2cc IV x 1 Placebo | 0 | 31 | 0 | 31 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |