Trial Outcomes & Findings for Vitamin D to ENhance TraUma REcovery (NCT NCT05458024)

Last Updated: 2025-03-28

Results Overview

Estimates of efficacy will be obtained via repeated measures analysis of pain severity over the 3 months following injury using mixed effects models. Pain will be assessed using a 0-10 numeric rating scale with 0 indicating no pain and 10 indicating pain as severe as one can imagine. Higher scores represent worse outcome. These values (collected in identical fashion over 3 months following motor vehicle collision) will be entered into a linear mixed model, and overall effect estimates (beta coefficients) among treatment groups will be determined

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Over 3 months following MVC

Results posted on

2025-03-28

Participant Flow

Participants presented to participating emergency departments after a motor vehicle collision. The first participant was enrolled on January 24, 2023 and the last participant was enrolled January 30, 2024

Of 233 participants who were screened for eligibility, 71 were enrolled and randomized to treatment

Participant milestones

Participant milestones
Measure	Ergocalciferol (Vitamin D2) 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These were given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo Inert substance was administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.
Overall Study STARTED	36	35
Overall Study Provided 3-Month Pain Data	20	23
Overall Study Complete 3-Month Follow Up Assessments	24	28
Overall Study COMPLETED	35	34
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ergocalciferol (Vitamin D2) 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These were given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo Inert substance was administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Vitamin D to ENhance TraUma REcovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ergocalciferol (Vitamin D2) n=36 Participants 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These were given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo n=35 Participants Inert substance was administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Total n=71 Participants Total of all reporting groups
Age, Continuous	36.8 Years STANDARD_DEVIATION 13.6 • n=5 Participants	35.2 Years STANDARD_DEVIATION 13.3 • n=7 Participants	36 Years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Pain	6.89 Score on a scale STANDARD_DEVIATION 1.97 • n=5 Participants	6.77 Score on a scale STANDARD_DEVIATION 1.83 • n=7 Participants	6.83 Score on a scale STANDARD_DEVIATION 1.89 • n=5 Participants
Vitamin D	18.2 ng/ml STANDARD_DEVIATION 11.4 • n=5 Participants	16.3 ng/ml STANDARD_DEVIATION 8.85 • n=7 Participants	17.3 ng/ml STANDARD_DEVIATION 10.2 • n=5 Participants

PRIMARY outcome

Timeframe: Over 3 months following MVC

Population: Data are reported for all participants who had 3-month pain data available.

Outcome measures

Outcome measures
Measure	Ergocalciferol (Vitamin D2) n=20 Participants 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These will be given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo n=23 Participants Inert substance will be administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: White Participants Non-Hispanic White participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: Black Participants Non-Hispanic Black participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.
Chronic Pain Severity 3 week pain	4.33 score on a scale Standard Deviation 2.81	5 score on a scale Standard Deviation 2.29	—	—
Chronic Pain Severity 4 week pain	4.39 score on a scale Standard Deviation 2.92	4.22 score on a scale Standard Deviation 2.04	—	—
Chronic Pain Severity 5 week pain	3.81 score on a scale Standard Deviation 2.80	3.92 score on a scale Standard Deviation 1.95	—	—
Chronic Pain Severity 6 week pain	3.29 score on a scale Standard Deviation 2.98	3.81 score on a scale Standard Deviation 2.48	—	—
Chronic Pain Severity 3 month pain	2.7 score on a scale Standard Deviation 2.98	3.0 score on a scale Standard Deviation 2.11	—	—

PRIMARY outcome

Timeframe: Over 3 months following MVC

Population: Data are reported for all participants who had 3-month pain data available.

Estimates of interaction between race and treatment assignment will be obtained via repeated measures analysis of pain severity over the 3 months following injury using mixed effects models. Pain will be assessed using a 0-10 numeric rating scale with 0 indicating no pain and 10 indicating pain as severe as one can imagine. Higher scores represent worse outcome. These values (collected in identical fashion over 3 months following burn injury) will be entered into a linear mixed model, and the beta coefficient for the race by treatment interaction term will be assessed.

Outcome measures

Outcome measures
Measure	Ergocalciferol (Vitamin D2) n=10 Participants 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These will be given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo n=10 Participants Inert substance will be administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: White Participants n=9 Participants Non-Hispanic White participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: Black Participants n=14 Participants Non-Hispanic Black participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.
Chronic Pain Race X Treatment Arm Interaction 3 week pain	3 score on a scale Standard Deviation 2	5.91 score on a scale Standard Deviation 2.88	4.3 score on a scale Standard Deviation 2.16	5.47 score on a scale Standard Deviation 2.33
Chronic Pain Race X Treatment Arm Interaction 4 week pain	2.69 score on a scale Standard Deviation 2.18	6.60 score on a scale Standard Deviation 2.22	3.78 score on a scale Standard Deviation 1.86	4.50 score on a scale Standard Deviation 2.18
Chronic Pain Race X Treatment Arm Interaction 5 week pain	2.23 score on a scale Standard Deviation 2.13	5.38 score on a scale Standard Deviation 2.53	2.78 score on a scale Standard Deviation 2.28	4.60 score on a scale Standard Deviation 1.4
Chronic Pain Race X Treatment Arm Interaction 6 week pain	1.79 score on a scale Standard Deviation 2.04	4.79 score on a scale Standard Deviation 3.07	3.30 score on a scale Standard Deviation 2.75	4.13 score on a scale Standard Deviation 2.33
Chronic Pain Race X Treatment Arm Interaction 3 month pain	1.00 score on a scale Standard Deviation 1.89	4.40 score on a scale Standard Deviation 2.95	2.56 score on a scale Standard Deviation 2.01	3.29 score on a scale Standard Deviation 2.20

PRIMARY outcome

Timeframe: 13 months of enrollment after the first participant

Population: Although the study originally planned to enroll for a total of 15 months, due to administrative funding delays the start date was delayed resulting in a 13-month enrollment window.

One feasibility measure of this study is demonstrating the ability to recruit 90 patients into the trial within 15 months of enrollment of the first participant. Feasibility of enrollment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.

Outcome measures

Outcome measures
Measure	Ergocalciferol (Vitamin D2) n=233 Participants 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These will be given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo Inert substance will be administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: White Participants Non-Hispanic White participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: Black Participants Non-Hispanic Black participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.
Enrollment of the 90-participant Sample Size During Enrollment Period (Feasibility)	71 Participants	—	—	—

PRIMARY outcome

Timeframe: through study completion, 3 months following MVC

Population: Data are reported for participants who completed various follow up assessments at the end of 3 months.

The primary objective of this study is to ensure that the investigators are able to make follow-up assessments on a majority of participants. The percent of participants who are compliant with follow-up will be determined 3 months following their motor vehicle collision. Feasibility is defined as \>80% of enrolled participants at 3 months following Motor Vehicle Collision (MVC).

Outcome measures

Outcome measures
Measure	Ergocalciferol (Vitamin D2) n=36 Participants 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These will be given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo n=35 Participants Inert substance will be administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: White Participants Non-Hispanic White participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.	Ergocalciferol Placebo: Black Participants Non-Hispanic Black participants given Inert substance administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.
Percent of Participants Who Are Compliant With Follow-up (Feasibility)	66.7 percent of participants	80.0 percent of participants	—	—

Adverse Events

Ergocalciferol (Vitamin D2)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Ergocalciferol Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ergocalciferol (Vitamin D2) n=36 participants at risk 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These will be given in a single dose prior to discharge from the Emergency Department.	Ergocalciferol Placebo n=35 participants at risk Inert substance will be administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.
Psychiatric disorders Distressing thoughts related to MVC	16.7% 6/36 • Number of events 6 • 30 days after receiving the study drug; participants received study drug within 24 hours of motor vehicle collision In addition to the clinicaltrials.gov definition, a preexisting condition was recorded as an adverse event if the frequency, intensity, or the character of the condition worsened during the study period. All unresolved adverse events were followed by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.	8.6% 3/35 • Number of events 3 • 30 days after receiving the study drug; participants received study drug within 24 hours of motor vehicle collision In addition to the clinicaltrials.gov definition, a preexisting condition was recorded as an adverse event if the frequency, intensity, or the character of the condition worsened during the study period. All unresolved adverse events were followed by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Psychiatric disorders Depression	5.6% 2/36 • Number of events 2 • 30 days after receiving the study drug; participants received study drug within 24 hours of motor vehicle collision In addition to the clinicaltrials.gov definition, a preexisting condition was recorded as an adverse event if the frequency, intensity, or the character of the condition worsened during the study period. All unresolved adverse events were followed by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.	0.00% 0/35 • 30 days after receiving the study drug; participants received study drug within 24 hours of motor vehicle collision In addition to the clinicaltrials.gov definition, a preexisting condition was recorded as an adverse event if the frequency, intensity, or the character of the condition worsened during the study period. All unresolved adverse events were followed by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Psychiatric disorders Distressing thoughts related to MVC and depression	2.8% 1/36 • Number of events 1 • 30 days after receiving the study drug; participants received study drug within 24 hours of motor vehicle collision In addition to the clinicaltrials.gov definition, a preexisting condition was recorded as an adverse event if the frequency, intensity, or the character of the condition worsened during the study period. All unresolved adverse events were followed by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.	8.6% 3/35 • Number of events 3 • 30 days after receiving the study drug; participants received study drug within 24 hours of motor vehicle collision In addition to the clinicaltrials.gov definition, a preexisting condition was recorded as an adverse event if the frequency, intensity, or the character of the condition worsened during the study period. All unresolved adverse events were followed by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.

Additional Information

Sam McLean, MD, MPH

University of North Carolina at Chapel Hill

Phone: +1 (919) 843-5931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place