Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (VIOLET-BUD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 7
- 主要终点
- 12-month Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in the VIOLET parent study
排除标准
- •Deaf or blind
- •Non-English speaking
研究组 & 干预措施
Intervention
Patients who received high dose D3 and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.
干预措施: 540,000 IU vitamin D3 (Drug)
Placebo
Patients who received placebo and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.
干预措施: Placebo (Drug)
结局指标
主要结局
12-month Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: 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. Scores range from 0 to 160 with 100 representing the population average. Higher score represents better cognition.
12-month Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales.
时间窗: 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 score. Scores range from 1 to 18; 10 is considered normal, and higher values indicate better executive function.
次要结局
- 12-month Functional Status as Measured by Katz Activities of Daily Living (ADL) Scale.(12 (+/- 4) months)
- 12-month Loss of Employment(12 (+/- 4) months)
- All-cause Mortality(12 (+/- 4) months)
- Nursing Home Residence at 12-months(12 (+/- 4) months)
- 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Immediate Memory Domain(12 (+/- 4) months)
- 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Visuospatial Construction Domain(12 (+/- 4) months)
- 12-month (Repeatable Battery for the Assessment of Neuropsychological Status) RBANS Language Domain(12 (+/- 4) months)
- 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Attention Domain(12 (+/- 4) months)
- 12-month Delayed Memory Domain(12 (+/- 4) months)
- Functional Status as Measured by the Lawton Instrumental Activities of Daily Living Scale.(12 months (+/- 4 months))
研究者
Jin H. Han
Associate Professor
Vanderbilt University Medical Center