Phase 3
N=30
Cholecalciferol Supplementation for Sepsis in the ICU
Hypovitaminosis D
Bottom Line
View on ClinicalTrials.gov: NCT01896544 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol — 19; 15; 17; 19 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cholecalciferol (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol |
19; 15; 17; 19; 22; 29 | — |
| SECONDARY Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol |
106; 208; 119; 53; 98; 31 | — |
| SECONDARY Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis |
8; 10; 10; 2; 0; 0 | — |
| SECONDARY Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis |
8; 10; 10; 2; 0; 0 | — |
| SECONDARY Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol |
106; 208; 119; 53; 98; 31 | — |
Summary
Sepsis in a clinical entity that occurs in patients with serious infections. Though the severity of illness may vary, every year, approximately 1.6 million Americans are treated for sepsis. Even with timely interventions, anywhere from 16% to >80% of patients with sepsis will not survive. Immune dysfunction is thought to play a critical role in the ability for infections to evolve into sepsis and to eventually lead to death. Recently, vitamin D has been identified as a key regulator of the immune system. While it remains unclear whether optimizing vitamin D status may improve outcomes in sepsis, little is known about the effects of vitamin D supplementation in patients with severe infections. As such, our goal is to study whether high doses of cholecalciferol (vitamin D3) can improve vitamin D status and boost certain aspects of the immune system in patients with sepsis.
Eligibility Criteria
Inclusion Criteria
- English or Spanish speaking
- Within 24 hours of a suspected diagnosis of sepsis
- Meeting criteria for sepsis (defined as suspected or confirmed infection AND at least one diagnostic criteria in each of the following groupings):
- Vital signs:
- Temperature: >38.3 Celsius (C) or 90/min, or >2 standard deviation above normal
- Tachypnea (>20 breaths per minute)
- Altered mental status
- Positive fluid balance (>20 mL/Kg over 24 hrs)
- Glucose >140 mg/dL in the absence of diabetes mellitus
- Inflammatory markers:
- white blood cell (WBC): >12,000 or 10% immature forms
- c-reactive protein (CRP) >2 standard deviation above normal value
- Pro- calcitonin >2 standard deviation above normal value
- Hemodynamic
- Systolic blood pressure (SBP) 40mmHg
- Vasopressor therapy to maintain MAP >65mmHg
- Organ dysfunction
- Arterial hypoxemia arterial oxygen partial pressure/fractional inspired oxygen (PaO2/FiO2) 0.5 mg/dL
- Coagulopathy: internationals normalized ratio (INR) >1.5 or a-partial prothrombin time (aPTT) >60 sec
- Thrombocytopenia: Platelet (PLT) 4 mg/dL
- Tissue perfusion
- Lactate >2 mmol/L
- Decrease cap refill or mottling
Exclusion Criteria
- Pregnant females or immediate post-partum status
- "Comfort measures only" status
- Inability to provide informed consent or have a surrogate consent
- History of renal stones within the past year
- History of hypercalcemia within the past year
- Baseline serum total calcium >10 mg/dL
- Established diagnosis associated with increased risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism)
- History of severe anemia (Hematocrit <25%)
- Medications that affect vitamin D metabolism (e.g. antiepileptics, tuberculosis medication
- Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings
Data sourced from ClinicalTrials.gov (NCT01896544). 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.