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

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT03733418

Acronym / sponsor ID

VIOLET-BUD / 181553

Conditions

Cognitive Decline

Keywords

vitamin D, cognitive decline, dementia, critical care

Study type

Observational

Recruitment status

Completed

Enrolment

95 participants (actual)

Lead sponsor

Vanderbilt University Medical CenterUniversity, hospital or other

Collaborators

Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, University of Colorado, Denver, Montefiore Medical Center, Intermountain Health Care, Inc., Oregon Health and Science University

Study start

1 Nov 2018 (actual)

Primary completion

2 Oct 2019 (actual)

Study completion

21 Feb 2020 (actual)

First posted

7 Nov 2018 (actual)

Results

Posted 21 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

584 patients enrolled in VIOLET.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 33819472Han 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.
• Pubmed link to manuscriptLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

7 sites in 1 country: see every site and its status.