Trial Outcomes & Findings for Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (NCT NCT03733418)

Last Updated: 2024-10-21

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

95 participants

Primary outcome timeframe

12 (+/- 4) months

Results posted on

2024-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D3 Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
Overall Study STARTED	47	48
Overall Study COMPLETED	47	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.	Total n=95 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	46.0 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	40 Participants n=5 Participants	31 Participants n=7 Participants	71 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiple race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Facility residence before hospitalization Home (independently)	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Facility residence before hospitalization Home (with help)	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Facility residence before hospitalization Home (with professional help)	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Facility residence before hospitalization Nursing facility	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Dementia	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Education, y	14 years n=5 Participants	14 years n=7 Participants	14 years n=5 Participants
Charlson Comorbidity Index	3 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants
Barona Index	107.7 units on a scale n=5 Participants	109.0 units on a scale n=7 Participants	108.4 units on a scale n=5 Participants
SOFA Score	4 units on a scale n=5 Participants	5 units on a scale n=7 Participants	5 units on a scale n=5 Participants
Infection (Sepsis + Pneumonia)	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 (+/- 4) months

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	79.6 units on a scale Interval 73.0 to 84.0	82.1 units on a scale Interval 74.7 to 84.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales.	8.1 units on a scale Interval 6.8 to 9.0	8.7 units on a scale Interval 7.4 to 9.3

SECONDARY outcome

Timeframe: 12 (+/- 4) months

The Katz ADL quantifies basic ADLs such as bathing, dressing, toileting, transferring, continence, and feeding. Scores range from 0 (completely dependent) to 6 (completely independent).

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Functional Status as Measured by Katz Activities of Daily Living (ADL) Scale.	6.0 score on a scale Interval 6.0 to 6.0	6.0 score on a scale Interval 6.0 to 6.0

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Population: Patients who were partially or fully employed prior to randomization.

Loss of employmentwas used using the Outcomes After Critical Illness and Surgery (OACIS) Employment Survey and characterizes the patient's baseline and current (12-month) employment status. Patients were defined as having a loss of employment if they went from full to partial or no employment or partial to no employment at 12 months.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=20 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=29 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Loss of Employment	7 Participants	10 Participants

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Patients were contacted and consented at the same time as the 12-month outcome assessments. Therefore, no patients who were enrolled in VIOLET-BUD died.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
All-cause Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Patient resides in a nursing home.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
Nursing Home Residence at 12-months	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Immediate memory is 1 of the 5 cognitive domains tested in the RBANS. Scores range from 40 to 160, with higher scores representing better immediate memory. A score of 100 represents the population average. The standard deviation for the population is 15.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Immediate Memory Domain	84.1 score on a scale Interval 80.2 to 89.0	87.6 score on a scale Interval 83.0 to 93.9

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Visuospatial construction is 1 of the 5 cognitive domains tested in the RBANS. Scores range from 40 to 160, with higher scores representing better visuospatial construction. A score of 100 represents the population average. The standard deviation for the population is 15.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Visuospatial Construction Domain	70.7 score on a scale Interval 66.0 to 75.9	68.7 score on a scale Interval 64.6 to 73.9

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Language is 1 of the 5 cognitive domains tested in the RBANS.Scores range from 40 to 160, with higher scores representing better language. A score of 100 represents the population average. The standard deviation for the population is 15.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month (Repeatable Battery for the Assessment of Neuropsychological Status) RBANS Language Domain	95.7 score on a scale Interval 90.1 to 97.4	95.6 score on a scale Interval 90.0 to 97.5

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Attention is 1 of the 5 cognitive domains tested in the RBANS. Scores range from 40 to 160, with higher scores representing better attention. A score of 100 represents the population average. The standard deviation for the population is 15.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Attention Domain	87.9 score on a scale Interval 80.7 to 95.0	90.1 score on a scale Interval 82.4 to 96.1

SECONDARY outcome

Timeframe: 12 (+/- 4) months

Delayed memory is 1 of the 5 cognitive domains tested in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Scores range from 40 to 160, with higher scores representing better delayed memory. A score of 100 represents the population average. The standard deviation for the population is 15.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
12-month Delayed Memory Domain	85.1 score on a scale Interval 81.4 to 91.3	84.6 score on a scale Interval 81.4 to 91.0

SECONDARY outcome

Timeframe: 12 months (+/- 4 months)

The Lawton IADL quantifies instrumental ADLs such using the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and finances. This scale ranges from 0 (completely dependent) to 8 (completely independent).

Outcome measures

Outcome measures
Measure	Vitamin D3 n=47 Participants Participants randomized to the vitamin D3 group received a single enteral (oral or enteral tube) dose of 540,000 IU vitamin D3 (cholecalciferol).	Placebo n=48 Participants Patients randomized to the control group received a placebo solution matched in appearance to the vitamin D3 solution.
Functional Status as Measured by the Lawton Instrumental Activities of Daily Living Scale.	8.0 score on a scale Interval 7.9 to 8.0	8.0 score on a scale Interval 8.0 to 8.0

Adverse Events

Vitamin D3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jin Han

Vanderbilt University Medical Center

Phone: 16159360253

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place