Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients

VIOLET-BUD is an ancillary study to a parent double-blinded, placebo-controlled randomized
control trial (RCT) evaluating how a single, high-dose (540,000 IU) oral Vitamin D3 treatment
affects 90-day mortality in patients who are at high risk for ARDS and have Vitamin D
deficiency (plasma 25-hydroxyvitamin D < 20 ng/ml) at enrollment. The parent RCT (Vitamin D
to Improve Outcomes by Leveraging Early Treatment [VIOLET], NCT03096314) is part of the
Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL)
sponsored by the NHLBI. The VIOLET trial completed enrollment in July 2018 with 1,360
randomized to either high dose, enteral Vitamin D3 or placebo.

This ancillary study will provide additional funding to perform comprehensive
neuropsychological (cognitive) evaluations, which were not part of the parent trial. These
neuropsychological evaluations will be conducted 12 (+/- 4) months after randomization among
a subset of 140 survivors enrolled in VIOLET. This ancillary study will conducted in 7 (out
of 42) sites.

Inclusion Criteria:

- Patients enrolled in the VIOLET parent study

Exclusion Criteria:

- Deaf or blind

- Non-English speaking