In critically ill, vitamin D-deficient patients admitted to the ICU, early administration of high-dose enteral vitamin D3 yielded similar 90-day mortality and nonfatal outcomes compared with placebo, according to new data from the VIOLET trial.
“A single 540,000 IU enteral dose of vitamin D3 administered early during critical illness rapidly corrected vitamin D deficiency but did not provide an advantage over placebo with respect to mortality or other clinically important endpoints. The very low likelihood of finding a benefit justified stopping the trial for futility before the pretrial sampling target of up to 3,000 patients had been reached,” researchers with the NHLBI PETAL Clinical Trials Network wrote in The New England Journal of Medicine.
The primary endpoint of 90-day all-cause and all-location mortality occurred in 23.5% of patients who received vitamin D within 12 hours after ICU admission vs. 20.6% of those who received placebo (difference, 2.9 percentage points; 95% CI, –2.1 to 7.9).
Observed mortality was higher with vitamin D administration in several subgroups, including patients with sepsis or infection and prehospital facility residence, pneumonia, infection and prerandomization acute respiratory distress syndrome.
“The higher observed mortality in the vitamin D group among patients with infectious causes of illness and patients with prerandomization acute respiratory distress syndrome was unexpected and contrary to the reported immunomodulatory effects of vitamin D. This observation may reflect differences between the use of vitamin D for prevention in previous studies and the use of vitamin D as treatment during acute illness in the present trial, but it also may be the result of chance,” the researchers wrote.
In critically ill, vitamin D-deficient patients admitted to the ICU, early administration of high-dose enteral vitamin D3 yielded similar 90-day mortality and nonfatal outcomes compared with placebo, according to new data from the VIOLET trial.
Source: Shutterstock
Severity of vitamin D deficiency at baseline did not affect the observed association between assignment to vitamin D or placebo and mortality, according to the researchers.
In other results, there were no differences between the vitamin D and placebo groups in secondary outcomes including mortality to day 28, hospital mortality to day 90, length of stay in hospital and health care facility, ventilator-free days and change in EQ-5D-5L score; physiological endpoints including respiratory, kidney and cardiovascular failure; and safety endpoints including calcium levels to day 14, incident kidney stones to day 90 and fall-related fractures to day 90.
The randomized, double-blind, placebo-controlled, phase 3 trial was performed at 44 U.S. hospitals from April 2017 to July 2018. Within 12 hours after ICU admission, patients were assigned a single dose of 540,000 IU vitamin D3 or matched placebo.
Patients enrolled presented with one or more acute risk factors for death or lung injury requiring ICU admission, including pneumonia, sepsis, shock, mechanical ventilation for acute respiratory failure, aspiration, smoke inhalation, pancreatitis or lung contusion. Pneumonia, shock and sepsis were the most common. In total, 1,360 patients had vitamin D deficiency at point-of-care screening; of those, 1,078 had baseline vitamin D deficiency (25-hydroxyvitamin D < 20 ng/mL) confirmed on subsequent tests, according to the researchers.
At day 3, the mean 25-hydroxyvitamin D level was 46.9 ng/mL among patients assigned vitamin D and 11.4 ng/mL among those assigned placebo.
The VIOLET trial was conducted as previous “observational data and initial clinical trial data indicate vitamin D deficiency is common among critically ill patients and constitutes a potentially modifiable risk factor associated with longer lengths of stay in the hospital and ICU, lung and other organ injury, prolonged mechanical ventilation and death,” the researchers wrote.
“The results of the present trial do not support early testing for or treatment of vitamin D deficiency in critically ill patients. Ongoing studies will evaluate the effect of vitamin D supplementation in patients with severe vitamin D deficiency, other subgroups of patients that may be more likely to benefit, and long-term outcomes,” the researchers wrote.
Disclosures: The VIOLET trial is supported by grants from the NHLBI. Sekisui Diagnostics supplied the FastPack IP systems and Bio-Tech Pharmacal developed and produced the high-dose vitamin D3 and placebo used in the trial.
In critically ill, vitamin D-deficient patients admitted to the ICU, early administration of high-dose enteral vitamin D3 yielded similar 90-day mortality and nonfatal outcomes compared with placebo, according to new data from the VIOLET trial.
“A single 540,000 IU enteral dose of vitamin D3 administered early during critical illness rapidly corrected vitamin D deficiency but did not provide an advantage over placebo with respect to mortality or other clinically important endpoints. The very low likelihood of finding a benefit justified stopping the trial for futility before the pretrial sampling target of up to 3,000 patients had been reached,” researchers with the NHLBI PETAL Clinical Trials Network wrote in The New England Journal of Medicine.
The primary endpoint of 90-day all-cause and all-location mortality occurred in 23.5% of patients who received vitamin D within 12 hours after ICU admission vs. 20.6% of those who received placebo (difference, 2.9 percentage points; 95% CI, –2.1 to 7.9).
Observed mortality was higher with vitamin D administration in several subgroups, including patients with sepsis or infection and prehospital facility residence, pneumonia, infection and prerandomization acute respiratory distress syndrome.
“The higher observed mortality in the vitamin D group among patients with infectious causes of illness and patients with prerandomization acute respiratory distress syndrome was unexpected and contrary to the reported immunomodulatory effects of vitamin D. This observation may reflect differences between the use of vitamin D for prevention in previous studies and the use of vitamin D as treatment during acute illness in the present trial, but it also may be the result of chance,” the researchers wrote.
In critically ill, vitamin D-deficient patients admitted to the ICU, early administration of high-dose enteral vitamin D3 yielded similar 90-day mortality and nonfatal outcomes compared with placebo, according to new data from the VIOLET trial.
Source: Shutterstock
Severity of vitamin D deficiency at baseline did not affect the observed association between assignment to vitamin D or placebo and mortality, according to the researchers.
In other results, there were no differences between the vitamin D and placebo groups in secondary outcomes including mortality to day 28, hospital mortality to day 90, length of stay in hospital and health care facility, ventilator-free days and change in EQ-5D-5L score; physiological endpoints including respiratory, kidney and cardiovascular failure; and safety endpoints including calcium levels to day 14, incident kidney stones to day 90 and fall-related fractures to day 90.
The randomized, double-blind, placebo-controlled, phase 3 trial was performed at 44 U.S. hospitals from April 2017 to July 2018. Within 12 hours after ICU admission, patients were assigned a single dose of 540,000 IU vitamin D3 or matched placebo.
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Patients enrolled presented with one or more acute risk factors for death or lung injury requiring ICU admission, including pneumonia, sepsis, shock, mechanical ventilation for acute respiratory failure, aspiration, smoke inhalation, pancreatitis or lung contusion. Pneumonia, shock and sepsis were the most common. In total, 1,360 patients had vitamin D deficiency at point-of-care screening; of those, 1,078 had baseline vitamin D deficiency (25-hydroxyvitamin D < 20 ng/mL) confirmed on subsequent tests, according to the researchers.
At day 3, the mean 25-hydroxyvitamin D level was 46.9 ng/mL among patients assigned vitamin D and 11.4 ng/mL among those assigned placebo.
The VIOLET trial was conducted as previous “observational data and initial clinical trial data indicate vitamin D deficiency is common among critically ill patients and constitutes a potentially modifiable risk factor associated with longer lengths of stay in the hospital and ICU, lung and other organ injury, prolonged mechanical ventilation and death,” the researchers wrote.
“The results of the present trial do not support early testing for or treatment of vitamin D deficiency in critically ill patients. Ongoing studies will evaluate the effect of vitamin D supplementation in patients with severe vitamin D deficiency, other subgroups of patients that may be more likely to benefit, and long-term outcomes,” the researchers wrote.
Disclosures: The VIOLET trial is supported by grants from the NHLBI. Sekisui Diagnostics supplied the FastPack IP systems and Bio-Tech Pharmacal developed and produced the high-dose vitamin D3 and placebo used in the trial.
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