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

Cognitive Decline Clinical Trial

— VIOLET-BUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733418
• Other study ID #: 181553
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: February 21, 2020

Study information

• Verified date: October 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 21, 2020
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients enrolled in the VIOLET parent study

Exclusion Criteria:

• Deaf or blind
• Non-English speaking

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Drug:
• 540,000 IU vitamin D3
This intervention was administered as part of VIOLET parent study. A single dose of 540,000 IU vitamin D3 was administered within 2 hours of randomization time.
• Placebo
Placebo was administered by the VIOLET parent study. A single, liquid enteral dose of placebo was administered.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Intermountain Medical Center	Murray	Utah
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Montefiore Medical Center	New York	New York
United States	Oregon Health and Science University Hospital	Portland	Oregon

Sponsors (7)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Intermountain Medical Center, Montefiore Medical Center, Oregon Health and Science University, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	The RBANS is a comprehensive neuropsychological battery for the evaluation of global cognition and has been validated in subjects with mild cognitive impairment, moderate to severe traumatic brain injuries, vascular dementias, and Alzheimer's disease. It specifically tests for for immediate and delayed memory, attention, visuospatial construction, and language.	12 (+/- 4) months
Primary	12-month executive function as measured by the components of the Delis-Kaplan Executive Function System (D-KEFS) subscales.	The D-KEF's Proverbs, Number-Letter Switching, and Verbal Fluency Category Switching subscales will measure conceptual flexibility, inhibition, and monitoring, respecitvely, which encompasses the majority of executive function. The average of the three subscales will provide an executive function composite	12 (+/- 4) months
Secondary	12-month functional status as measured by the Katz Activities of Daily Living (ADL) and Lawton Instrumental Activities of Daily Living (IADL) scales.	The Katz ADL quantifies basic ADLs such as bathing, dressing, toileting, transferring, continence, and feeding. The Lawton IADL quantifies instrumental ADLs such using the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and finances. For the analysis, the Katz ADL and Lawton IADL scales will be summed to provide a functional status score.	12 (+/- 4) months
Secondary	12-month employment as measured by the Outcomes After Critical Illness and Surgery (OACIS) Employment Survey.	The OACIS employment survey will characterize the patient's baseline and current (12 month) employment status.	12 (+/- 4) months
Secondary	12-month death	The patient's death status and time of death will be established during phone contact or medical record review.	12 (+/- 4) months
Secondary	12-month place of residence	12-month residence status (e.g, home, assisted living, nursing home, etc.,) will be collected during phone contact or medical record review.	12 (+/- 4) months
Secondary	12-month immediate memory	Immediate memory is 1 of the 5 cognitive domains tested in the RBANS.	12 (+/- 4) months
Secondary	12-month visuospatial ability	Visuospatial is 1 of the 5 cognitive domains tested in the RBANS.	12 (+/- 4) months
Secondary	12-month language	Language is 1 of the 5 cognitive domains tested in the RBANS.	12 (+/- 4) months
Secondary	12-month attention	Attention is 1 of the 5 cognitive domains tested in the RBANS.	12 (+/- 4) months
Secondary	12-month delayed memory	Delayed memory is 1 of the 5 cognitive domains tested in the RBANS.	12 (+/- 4) months

External Links

•   Publisher link to manuscript
•   Pubmed link to manuscript