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

Vanderbilt University Medical Center

Status: Completed

Conditions: Cognitive Decline

Treatments: Drug: Placebo; Drug: 540,000 IU vitamin D3

Study type: Observational

Funder types: Other

Identifiers

NCT03733418

181553

Details and patient eligibility

About

This ancillary study will determine if early administration of a single high-dose (540,000 IU) oral vitamin D3 (cholecalciferol) treatment improves 12-month global cognition and executive function as determined by comprehensive neuropsychological testing in 140 critically ill patients with Vitamin D deficiency at enrollment.

Full description

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients enrolled in the VIOLET parent study

Exclusion criteria

• Deaf or blind
• Non-English speaking

Trial design

95 participants in 2 patient groups

Intervention

Description:

Patients who received high dose D3 and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.

Treatment:

Drug: 540,000 IU vitamin D3

Placebo

Description:

Patients who received placebo and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.

Treatment:

Drug: Placebo