Details

Autor(en) / Beteiligte

• Ginde, Adit A
• Brower, Roy G
• Caterino, Jeffrey M
• Finck, Lani
• Banner-Goodspeed, Valerie M
• Grissom, Colin K
• Hayden, Douglas
• Hough, Catherine L
• Hyzy, Robert C
• Khan, Akram
• Levitt, Joseph E
• Park, Pauline K
• Ringwood, Nancy
• Rivers, Emanuel P
• Self, Wesley H
• Shapiro, Nathan I
• Thompson, B Taylor
• Yealy, Donald M
• Talmor, Daniel

Titel

Early High-Dose Vitamin D 3 for Critically Ill, Vitamin D-Deficient Patients

Ist Teil von

• The New England journal of medicine, 2019-12, Vol.381 (26), p.2529-2540

Ort / Verlag

United States

Erscheinungsjahr

2019

Quelle

MEDLINE

Beschreibungen/Notizen

• Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study. We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D or matched placebo. The primary end point was 90-day all-cause, all-location mortality. A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, -2.1 to 7.9; P = 0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality. Early administration of high-dose enteral vitamin D did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients. (Funded by the National Heart, Lung, and Blood Institute; VIOLET ClinicalTrials.gov number, NCT03096314.).