Clinical trial NCT03733418: Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients
Official title: Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (VIOLET-BUD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Decline
Keywords: vitamin D
cognitive decline
dementia
critical care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: University of Colorado, Denver
name: Montefiore Medical Center
name: Intermountain Medical Center
name: Oregon Health and Science University
First posted: 2018-11-07
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 584 patients enrolled in VIOLET.

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients enrolled in the VIOLET parent study

Exclusion Criteria:

* Deaf or blind
* Non-English speaking

Primary outcomes:
measure: 12-month Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 12 (+/- 4) months
measure: 12-month Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales.
timeFrame: 12 (+/- 4) months
Secondary outcomes:
measure: 12-month Functional Status as Measured by Katz Activities of Daily Living (ADL) Scale.
timeFrame: 12 (+/- 4) months
measure: 12-month Loss of Employment
timeFrame: 12 (+/- 4) months
measure: All-cause Mortality
timeFrame: 12 (+/- 4) months
measure: Nursing Home Residence at 12-months
timeFrame: 12 (+/- 4) months
measure: 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Immediate Memory Domain
timeFrame: 12 (+/- 4) months
measure: 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Visuospatial Construction Domain
timeFrame: 12 (+/- 4) months
measure: 12-month (Repeatable Battery for the Assessment of Neuropsychological Status) RBANS Language Domain
timeFrame: 12 (+/- 4) months
measure: 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Attention Domain
timeFrame: 12 (+/- 4) months
measure: 12-month Delayed Memory Domain
timeFrame: 12 (+/- 4) months
measure: Functional Status as Measured by the Lawton Instrumental Activities of Daily Living Scale.
timeFrame: 12 months (+/- 4 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University Hospital
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jin H. Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han JH, Ginde AA, Brown SM, Baughman A, Collar EM, Ely EW, Gong MN, Hope AA, Hou PC, Hough CL, Iwashyna TJ, Jackson JC, Khan A, Orun OM, Patel MB, Raman R, Rice TW, Ringwood N, Semler MW, Shapiro NI, Talmor DS, Self WH; Vitamin D to Improve Outcomes by Leveraging Early Treatment Network Investigators. Effect of Early High-Dose Vitamin D3 Repletion on Cognitive Outcomes in Critically Ill Adults. Chest. 2021 Sep;160(3):909-918. doi: 10.1016/j.chest.2021.03.046. Epub 2021 Apr 2.