N/A
N=95
Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients
Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT03733418 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: 12-month Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) — 79.6; 82.1 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 540,000 IU vitamin D3 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12-month Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |
79.6; 82.1 | — |
| PRIMARY 12-month Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales. |
8.1; 8.7 | — |
| SECONDARY 12-month Functional Status as Measured by Katz Activities of Daily Living (ADL) Scale. |
6.0; 6.0 | — |
| SECONDARY 12-month Loss of Employment |
7; 10 | — |
| SECONDARY All-cause Mortality |
0; 0 | — |
| SECONDARY Nursing Home Residence at 12-months |
1; 1 | — |
| SECONDARY 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Immediate Memory Domain |
84.1; 87.6 | — |
| SECONDARY 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Visuospatial Construction Domain |
70.7; 68.7 | — |
| SECONDARY 12-month (Repeatable Battery for the Assessment of Neuropsychological Status) RBANS Language Domain |
95.7; 95.6 | — |
| SECONDARY 12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Attention Domain |
87.9; 90.1 | — |
| SECONDARY 12-month Delayed Memory Domain |
85.1; 84.6 | — |
| SECONDARY Functional Status as Measured by the Lawton Instrumental Activities of Daily Living Scale. |
8.0; 8.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients enrolled in the VIOLET parent study
Exclusion Criteria
- Deaf or blind
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT03733418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.