CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 95 enrolled
Drug / intervention
540,000 IU vitamin D3 +1 moredrug
Likely dose
540,000 IU vitamin D3from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03733418
NCT03733418N/ACompleted
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Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (VIOLET-BUD)

Vanderbilt University Medical Center·observational·Posted Nov 7, 2018·Updated Oct 21, 2024

In Brief

An observational study evaluating 540,000 IU vitamin D3 and Placebo for Cognitive Decline. Completed, enrolled 95 participants across 7 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCognitive Decline
CountriesUnited States
CollaboratorsBeth Israel Deaconess Medical Center, Brigham and Women's Hospital, University of Colorado, Denver, Montefiore Medical Center, Intermountain Medical Center, Oregon Health and Science University

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 7, 2018
Enrollment StartNov 1, 2018
Primary CompletionOct 2, 2019
Study CompletionFeb 21, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.7 years ago

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.

Placebodrug

Placebo that matched the vitamin D3 color was provided.