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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
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
University of Colorado, Denver
Montefiore Medical Center
Intermountain Medical Center
Oregon Health and Science University
Information provided by (Responsible Party):
Jin H. Han, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Cognitive Decline Drug: 540,000 IU vitamin D3 Drug: Placebo

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.


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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Group/Cohort Intervention/treatment
VIOLET participants
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

Drug: Placebo
Placebo was administered by the VIOLET parent study. A single, liquid enteral dose of placebo was administered.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 12-month immediate memory [ Time Frame: 12 (+/- 4) months ]
    Immediate memory is 1 of the 5 cognitive domains tested in the RBANS.

  6. 12-month visuospatial ability [ Time Frame: 12 (+/- 4) months ]
    Visuospatial is 1 of the 5 cognitive domains tested in the RBANS.

  7. 12-month language [ Time Frame: 12 (+/- 4) months ]
    Language is 1 of the 5 cognitive domains tested in the RBANS.

  8. 12-month attention [ Time Frame: 12 (+/- 4) months ]
    Attention is 1 of the 5 cognitive domains tested in the RBANS.

  9. 12-month delayed memory [ Time Frame: 12 (+/- 4) months ]
    Delayed memory is 1 of the 5 cognitive domains tested in the RBANS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
140 survivors enrolled in VIOLET.
Criteria

Inclusion Criteria:

  • Patients enrolled in the VIOLET parent study

Exclusion Criteria:

  • Deaf or blind
  • Non-English speaking

Information from the National Library of Medicine

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


Contacts
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Contact: Jin H. Han, MD 615-936-0253 jin.h.han@vumc.org
Contact: Karen F. Miller, RN 615-936-4790 karen.f.miller@vumc.org

Locations
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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         
Sponsors and Collaborators
Vanderbilt University Medical Center
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
University of Colorado, Denver
Montefiore Medical Center
Intermountain Medical Center
Oregon Health and Science University
Investigators
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Principal Investigator: Jin H. Han, MD Vanderbilt University Medical Center

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Responsible Party: Jin H. Han, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03733418     History of Changes
Other Study ID Numbers: 181553
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

This data sharing plan is only pertinent to data collected specifically for VIOLET-BUD. Because VIOLET-BUD is an ancillary study to a Prevention and Early Treatment of Acute Lung Injury (PETAL) network study, the same data sharing plan will be instituted as the PETAL Clinical Coordinating Center. Limited access data sets will be prepared and provided to the NHLBI in accordance with National, Heart, Lung and Blood Institute (NHLBI) policies on data sharing: http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.

VIOLET-BUD data will be made available on the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). In addition to the data, documentation such as data collection forms, study procedures and protocols, data dictionaries and algorithms for calculated data elements and descriptions of all variable recoding performed will also be provided.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be available after the publication of the primary manuscript.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin H. Han, Vanderbilt University Medical Center:
vitamin D
cognitive decline
dementia
critical care
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents