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



Status:Recruiting
Conditions:Cognitive Studies, Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:November 1, 2018
End Date:October 31, 2020
Contact:Jin H. Han, MD
Email:jin.h.han@vumc.org
Phone:615-936-0253

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

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.

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
We found this trial at
7
sites
New York, New York 10467
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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Portland, OR
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