Trial Outcomes & Findings for Hypovitaminosis D in Neurocritical Patients (NCT NCT02881957)

NCT ID: NCT02881957

Last Updated: 2022-06-15

Results Overview

Intent-to-treat hospital length-of-stay

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 274 participants
• Primary outcome timeframe: Until discharge
• Results posted on: 2022-06-15

Participant Flow

Participant milestones

Measure	Placebo Placebo control (simple oral syrup) Placebo: Oral syrup placebo	Vitamin D3 Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once) Cholecalciferol
Overall Study STARTED	136	138
Overall Study COMPLETED	133	134
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Placebo Placebo control (simple oral syrup) Placebo: Oral syrup placebo	Vitamin D3 Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once) Cholecalciferol
Overall Study Comfort care	0	1
Overall Study Concurrent trial enrollment	0	1
Overall Study Discharged within 48 hours	0	1
Overall Study Withdrawal by Subject	2	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Hypovitaminosis D in Neurocritical Patients

Baseline characteristics by cohort

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo	Total n=267 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 17.5 • n=93 Participants	55.1 years STANDARD_DEVIATION 16.8 • n=4 Participants	54.0 years STANDARD_DEVIATION 17.2 • n=27 Participants
Sex: Female, Male Female	56 Participants n=93 Participants	59 Participants n=4 Participants	115 Participants n=27 Participants
Sex: Female, Male Male	78 Participants n=93 Participants	74 Participants n=4 Participants	152 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=93 Participants	15 Participants n=4 Participants	25 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants n=93 Participants	102 Participants n=4 Participants	216 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=93 Participants	16 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	107 Participants n=93 Participants	99 Participants n=4 Participants	206 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=93 Participants	23 Participants n=4 Participants	41 Participants n=27 Participants
Region of Enrollment United States	134 Participants n=93 Participants	133 Participants n=4 Participants	267 Participants n=27 Participants

PRIMARY outcome

Timeframe: Until discharge

Intent-to-treat hospital length-of-stay

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
Intent-to-treat Hospital Length-of-stay	10.9 days Standard Deviation 15.6	9.1 days Standard Deviation 7.9

PRIMARY outcome

Timeframe: Until discharge

Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients after randomization, factoring excluded patients (e.g., as-treated) using a p<0.05 as significant.

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
As-treated Hospital Length of Stay	10.4 days Standard Deviation 14.5	9.1 days Standard Deviation 7.9

SECONDARY outcome

Timeframe: Until discharge

Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization (e.g., intent-to-treat) using a p<0.05 as significant.

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
Intent-to-treat ICU Length of Stay	6.4 days Standard Deviation 9.8	5.4 days Standard Deviation 6.4

SECONDARY outcome

Timeframe: Until discharge

Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization but excluding patients who did not receive treatment (e.g., as-treated) using a p<0.05 as significant.

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
As-treated ICU Length of Stay	5.8 days Standard Deviation 7.5	5.4 days Standard Deviation 6.4

SECONDARY outcome

Timeframe: Until discharge

In-hospital mortality

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
In-hospital Mortality	11 Participants	13 Participants

SECONDARY outcome

Timeframe: Until discharge

The occurrence of patients who suffered mortality, adverse events or severe adverse events, related specifically to the study drug was monitored. Severe adverse events are defined using common terminology criteria for adverse events (CTCAE) grade 3 or higher specific to vitamin D from time of study drug administration to discharge.

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
Number of Participants With Study Drug Related Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Until discharge

Diagnosis of sepsis

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
Number of Participants With Sepsis	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Until discharge

Pneumonia diagnosis

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
Number of Participants With Pneumonia	16 Participants	14 Participants

SECONDARY outcome

Timeframe: Until discharge

Urinary tract infection diagnosis

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
Number of Participants With Urinary Tract Infection	9 Participants	6 Participants

SECONDARY outcome

Timeframe: Until discharge

Deep vein thrombosis diagnosis

Outcome measures

Measure	Vitamin D3 n=134 Participants Patient demographics of patients receiving study drug	Placebo n=133 Participants Patient demographics of patients receiving placebo
Number of Participants With Deep Vein Thrombosis	8 Participants	3 Participants

Adverse Events

Vitamin D3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Karsy

University of Utah

Phone: 801-581-6908

Email: michael.karsy@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place