NCT03733418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

October 21, 2024

Completed
Last Updated

October 21, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

October 30, 2018

Results QC Date

February 23, 2022

Last Update Submit

August 1, 2024

Conditions

Cognitive Decline

Keywords

vitamin Dcognitive declinedementiacritical care

Outcome Measures

Primary Outcomes (2)

  • 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. Scores range from 0 to 160 with 100 representing the population average. Higher score represents better cognition.

    12 (+/- 4) months

  • 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 score. Scores range from 1 to 18; 10 is considered normal, and higher values indicate better executive function.

    12 (+/- 4) months

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Intervention

Patients who received high dose D3 and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.

Drug: 540,000 IU vitamin D3

Placebo

Patients who received placebo and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.

Drug: Placebo

Interventions

540,000 IU vitamin D3DRUG

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.

Also known as: Cholecalciferol
Intervention
PlaceboDRUG

Placebo that matched the vitamin D3 color was provided.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

584 patients enrolled in VIOLET.

You may qualify if:

  • Patients enrolled in the VIOLET parent study

You may not qualify if:

  • Deaf or blind
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Oregon Health and Science University Hospital

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Related Publications (1)

  • Han JH, Ginde AA, Brown SM, Baughman A, Collar EM, Ely EW, Gong MN, Hope AA, Hou PC, Hough CL, Iwashyna TJ, Jackson JC, Khan A, Orun OM, Patel MB, Raman R, Rice TW, Ringwood N, Semler MW, Shapiro NI, Talmor DS, Self WH; Vitamin D to Improve Outcomes by Leveraging Early Treatment Network Investigators. Effect of Early High-Dose Vitamin D3 Repletion on Cognitive Outcomes in Critically Ill Adults. Chest. 2021 Sep;160(3):909-918. doi: 10.1016/j.chest.2021.03.046. Epub 2021 Apr 2.

    PMID: 33819472DERIVED

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Jin Han
Organization
Vanderbilt University Medical Center
jin.h.han@vumc.org
16159360253

Study Officials

  • Jin H. Han, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 7, 2018

Study Start

November 1, 2018

Primary Completion

October 2, 2019

Study Completion

February 21, 2020

Last Updated

October 21, 2024

Results First Posted

October 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be available after the publication of the primary manuscript.

Locations

US(7)