Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (VIOLET-BUD)
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|ClinicalTrials.gov Identifier: NCT03733418|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment|
|Cognitive Decline||Drug: 540,000 IU vitamin D3 Drug: Placebo|
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.
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (VIOLET-BUD)|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2020|
Neuropsychological evaluations will be conducted 12 (+/-4) months after randomization among a subset of 140 survivors enrolled in the VIOLET parent study at 7 (out of 42) PETAL sites.
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.
Other Name: Cholecalciferol
Placebo was administered by the VIOLET parent study. A single, liquid enteral dose of placebo was administered.
- 12-month cognition as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 12 (+/- 4) months ]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-month executive function as measured by the components of the Delis-Kaplan Executive Function System (D-KEFS) subscales. [ Time Frame: 12 (+/- 4) months ]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-month functional status as measured by the Katz Activities of Daily Living (ADL) and Lawton Instrumental Activities of Daily Living (IADL) scales. [ Time Frame: 12 (+/- 4) months ]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-month employment as measured by the Outcomes After Critical Illness and Surgery (OACIS) Employment Survey. [ Time Frame: 12 (+/- 4) months ]The OACIS employment survey will characterize the patient's baseline and current (12 month) employment status.
- 12-month death [ Time Frame: 12 (+/- 4) months ]The patient's death status and time of death will be established during phone contact or medical record review.
- 12-month place of residence [ Time Frame: 12 (+/- 4) months ]12-month residence status (e.g, home, assisted living, nursing home, etc.,) will be collected during phone contact or medical record review.
- 12-month immediate memory [ Time Frame: 12 (+/- 4) months ]Immediate memory is 1 of the 5 cognitive domains tested in the RBANS.
- 12-month visuospatial ability [ Time Frame: 12 (+/- 4) months ]Visuospatial is 1 of the 5 cognitive domains tested in the RBANS.
- 12-month language [ Time Frame: 12 (+/- 4) months ]Language is 1 of the 5 cognitive domains tested in the RBANS.
- 12-month attention [ Time Frame: 12 (+/- 4) months ]Attention is 1 of the 5 cognitive domains tested in the RBANS.
- 12-month delayed memory [ Time Frame: 12 (+/- 4) months ]Delayed memory is 1 of the 5 cognitive domains tested in the RBANS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733418
|Contact: Jin H. Han, MDemail@example.com|
|Contact: Karen F. Miller, RNfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Adit Ginde, MD, MPH|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Peter Hou, MD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Nathan Shapiro, MD, MPH|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|New York, New York, United States, 10467|
|Contact: Michelle Gong, MD|
|United States, Oregon|
|Oregon Health and Science University Hospital||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Akram Khan, MD|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Wesley H Self, MD, MPH|
|United States, Utah|
|Intermountain Medical Center||Recruiting|
|Murray, Utah, United States, 84107|
|Contact: Samuel Brown, MD, MS|
|Principal Investigator:||Jin H. Han, MD||Vanderbilt University Medical Center|