Early High-Dose Vitamin D3 for Critically Ill, Vitamin D-Deficient Patients
National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, Ginde AA, Brower RG, Caterino JM, Finck L, Banner-Goodspeed VM, Grissom CK, Hayden D, Hough CL, Hyzy RC, Khan A, Levitt JE, Park PK, Ringwood N, Rivers EP, Self WH, Shapiro NI, Thompson BT, Yealy DM, Talmor D
The New England journal of medicine · 218 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Independent funding
- Government
- National Heart, Lung, and Blood Institute
- Government
- NHLBI NIH HHS
- Government
- United States
- Grants
- National Heart, Lung, and Blood Institute (U01 HL123018); National Heart, Lung, and Blood Institute (U01HL123022); National Heart, Lung, and Blood Institute (U01 HL123023); National Heart, Lung, and Blood Institute (U01 HL123027); National Heart, Lung, and Blood Institute (U01HL123010, U01HL123033, U01HL122989, U01HL123022); National Heart, Lung, and Blood Institute (U01 HL123010); National Heart, Lung, and Blood Institute (U01HL123009); National Heart, Lung, and Blood Institute (U01 HL123033); National Heart, Lung, and Blood Institute (U01HL122998); National Heart, Lung, and Blood Institute (U01HL123008, U01HL123031, U01HL123004, U01HL123027); National Heart, Lung, and Blood Institute (U01 HL123008); National Heart, Lung, and Blood Institute (U01HL123031); National Heart, Lung, and Blood Institute (U01 HL122989); National Heart, Lung, and Blood Institute (U01HL123009, U01HL122998, U01HL123018, U01HL123023); National Heart, Lung, and Blood Institute (U01 HL123004); National Heart, Lung, and Blood Institute (U01HL123020)
Based on 3 listed funder(s).
Publication
- Published
- 2019-12-11 · N Engl J Med · vol. 381 · issue 26 · pp. 2529–2540
- Publisher
- Massachusetts Medical Society
- Cited
- 312 citations · more than 100% of similar papers · 25.3× the field average
- Impact
- Top 10% most cited in its field
- References
- 28 works
- Access
- Free to read
- Research areas
- Vitamin D Research Studies · Vitamin C and Antioxidants Research · Parathyroid Disorders and Treatments
- Keywords
- Critically ill, Vitamin, Vitamin D and neurology, Medicine, Intensive care medicine, Internal medicine
- MeSH
- humans, vitamin d deficiency, critical illness, cholecalciferol, vitamins, vitamin d, treatment failure, length of stay, double-blind method, adult, middle aged, female, male, kaplan-meier estimate, organ dysfunction scores
1 author
- The National Heart, Lung, and Blood Institute PETAL Clinical Trials Network · corresponding
Abstract
Background
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.
Methods
We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 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 D3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality.
Results
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.
Conclusions
Early administration of high-dose enteral vitamin D3 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.).
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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