This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Vitamin D to ENhance TraUma REcovery (NCT05458024), a randomized phase 2 study. The primary outcome is Chronic Pain Severity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05458024 |
| Phase | Phase 2 |
| Condition | Musculoskeletal Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 71 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Results posted | Yes |
2. Clinical Question
Population
People experiencing musculoskeletal pain after a motor vehicle collision (MVC), with primary-outcome reporting described for participants who had 3-month pain data available. The registry record does not report the number with those data or additional eligibility details.
Intervention
A single dose of 300,000 international units (IUs) of Ergocalciferol (Vitamin D2), given as 6 50,000 IU capsules prior to discharge from the Emergency Department.
Comparator
An inert placebo administered in 6 capsules described as indistinguishable from the active-treatment capsules.
Primary question
Whether assignment to vitamin D2 rather than placebo changes musculoskeletal pain severity over 3 months following MVC, and whether treatment can reduce the stated disparity in pain outcomes between Black and White participants. Numerical estimates for the primary analysis are not reported in the registry record.
The trial title and summary frame the question around chronic pain following MVC and a possible racial disparity in pain outcomes. Its stated objective includes both pain severity and disparity, while the primary outcome description specifies repeated measurement of pain severity over the period following injury. The record does not report a numerical estimate for the treatment-group contrast, an estimate of a race-related contrast, or an interaction estimate addressing whether the treatment effect differed by race. Accordingly, the clinical question is identifiable, but its answer cannot be determined from the posted primary-outcome results because those results are not reported in the registry record.
The study is described as a pilot intended to assess feasibility and potential efficacy and to inform a larger trial. That purpose matters when interpreting any planning calculations: they do not replace observed estimates, and a pilot is not necessarily designed to provide a conclusive efficacy assessment. The registry record does not report specific feasibility outcomes or numerical primary pain results.
3. Trial Design
This was a completed, randomized, quadruple-masked, parallel-group phase 2 trial sponsored by the University of North Carolina, Chapel Hill. The registry record reports enrollment of 71. The study began on 2023-01-24, and its primary completion date was 2024-05-01. It compared Ergocalciferol (Vitamin D2) with an Ergocalciferol placebo after motor vehicle collision.
The active arm received a single dose of 300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules before discharge from the Emergency Department. The placebo arm received an inert substance in 6 capsules described as indistinguishable from the active capsules. Random allocation and masking are reported, but the method used to generate or conceal the allocation sequence is not reported in the registry record. The record also does not identify which roles were included in quadruple masking or describe procedures for maintaining masking.
The parallel design assigns participants to one of the intervention groups rather than describing a crossover between treatments. The main outcome was chronic pain severity, assessed repeatedly over 3 months following MVC. The registry record describes a linear mixed model for repeated pain scores. It says primary-outcome data are reported for all participants with 3-month pain data available; the number of participants meeting that condition is not reported in the registry record.
The study is explicitly characterized as a pilot, with feasibility and potential efficacy as its stated aims. That context distinguishes the trial from a definitive evaluation: a pilot can help inform a later study, but the record does not report a specific decision threshold for proceeding or a sample-size justification. The registry record lists 4 outcome measures and 2 analyses, but it does not report enough detail to establish the full analysis plan, analysis populations, or whether all planned analyses were completed.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Of 233 participants who were screened for eligibility, 71 were enrolled and randomized to treatment
Overall Study
| Stage | Ergocalciferol (Vitamin D2) | Ergocalciferol Placebo |
|---|---|---|
| STARTED | 36 | 35 |
| Provided 3-Month Pain Data | 20 | 23 |
| Complete 3-Month Follow Up Assessments | 24 | 28 |
| COMPLETED | 35 | 34 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Ergocalciferol (Vitamin D2) | Ergocalciferol Placebo |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Data are reported for all participants who had 3-month pain data available.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Ergocalciferol (Vitamin D2) | Ergocalciferol Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 36 | 35 | 71 | |
| Age, Continuous | Years | 36.8 (SD 13.6) | 35.2 (SD 13.3) | 36 (SD 13.4) |
| Sex: Female, Male: Female | Participants | 19 | 17 | 36 |
| Sex: Female, Male: Male | Participants | 17 | 18 | 35 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 36 | 35 | 71 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 20 | 21 | 41 |
| Race (NIH/OMB): White | Participants | 16 | 14 | 30 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 36 | 35 | 71 |
| Pain | Score on a scale | 6.89 (SD 1.97) | 6.77 (SD 1.83) | 6.83 (SD 1.89) |
| Vitamin D | ng/ml | 18.2 (SD 11.4) | 16.3 (SD 8.85) | 17.3 (SD 10.2) |
6. Primary Endpoint
The registry lists the primary outcome as Chronic Pain Severity, measured over Over 3 months following MVC.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is chronic pain severity, represented by a score on a 0-10 numeric rating scale. The record describes 0 as no pain and 10 as pain as severe as one can imagine; higher scores indicate a worse outcome. The score was to be assessed repeatedly over 3 months following MVC.
Repeated pain measurements can describe the pattern of pain over time more fully than a single assessment. The stated analysis uses a linear mixed model to estimate an overall treatment-group effect from measurements collected in the same way during the follow-up period. General: mixed models are designed to account for the fact that repeated observations from the same participant are related, rather than treating every measurement as independent. They can also use available repeated observations, subject to the model and assumptions used.
The endpoint is relevant to the stated objective because it measures the severity of musculoskeletal pain after injury. However, the registry record does not report the numerical estimate of the treatment contrast, its confidence interval, a p-value, or group-level pain summaries. It therefore does not allow readers to assess the direction, size, or precision of the primary treatment comparison. The record also does not report a specific numerical endpoint for the disparity objective.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary question and the planned model, but does not report numerical results from the chronic pain analysis. There is no posted treatment-effect estimate, confidence interval, p-value, or group-level mean for the primary endpoint in the registry record described for this trial. The direction and magnitude of the difference between vitamin D2 and placebo therefore cannot be assessed from the registry record. Nor can its precision be judged. This absence should not be interpreted as evidence that the groups had the same pain outcomes; it means the primary numerical comparison is not reported in the registry record.
The stated endpoint is pain severity on a 0-10 scale, measured over 3 months following MVC. The registry record says a linear mixed model was intended to estimate overall effects between treatment groups using repeated observations. An effect estimate from that model would be needed to describe the observed contrast, and a confidence interval would help show the range of values compatible with the analysis. General: a confidence interval conveys uncertainty around an estimate; a narrower interval indicates greater precision, while an interval spanning effects in different directions may leave the interpretation uncertain. No such interval is reported for the primary outcome in the registry record.
The study's stated aim also includes reducing disparity in pain outcomes between Black and White participants. The registry record does not report race-specific pain estimates, an interaction analysis, or other numerical results that would establish whether outcomes differed across those groups or whether any treatment contrast varied by race. An overall treatment comparison alone would not answer that separate disparity question.
Safety reporting gives a limited numerical picture. The record lists 0 serious adverse events among 36 participants at risk in the Ergocalciferol group and 0 among 35 participants at risk in the placebo group. It lists 9 affected by other adverse events in the Ergocalciferol group and 6 in the placebo group, and 0 deaths in each group. The record does not provide event terms or further detail in the registry record. These counts should be read as the posted safety figures, not as a complete account of the nature, timing, or severity of all events.
The trial enrolled 71 and is described as a pilot. The primary-outcome population is defined as participants with 3-month pain data available, but its size is not reported in the registry record. Consequently, the relationship between enrollment and the analyzed primary-outcome data cannot be assessed. The registry record also does not report the sample-size justification or a numerical result that would support a definitive efficacy conclusion. Planning calculations, if considered, are illustrations based on an observed effect and are not observed power; the registry record's lack of primary estimates prevents those planning values from being independently interpreted.
9. Statistical Methods Explained
The registry record describes repeated pain measurements analyzed with a linear mixed model. The outcome is continuous: a score on a 0-10 numeric rating scale, with higher scores representing worse pain. The record specifies that results are expressed as a mean with standard deviation and that overall effect estimates are beta coefficients. It does not report the fitted coefficient or its uncertainty for the primary comparison.
Why use a mixed model for repeated pain scores?
General: repeated measurements from one person tend to be more alike than measurements from unrelated people. A model that treats every measurement as independent can misrepresent the amount of information and the uncertainty in the treatment comparison. A mixed model can account for within-person correlation while estimating group differences over time. It can also accommodate observations collected at different follow-up occasions, depending on the exact model specification.
The registry record states that pain was assessed in an identical fashion over 3 months and entered into a linear mixed model. It does not report the exact visit schedule, the model's fixed or random effects, the covariance structure, adjustment variables, or whether the treatment effect was allowed to vary over time. Those details matter because different specifications can produce different estimates and uncertainty. The record also does not report how the model handled participants with incomplete repeated measurements, or the assumptions used for any such handling.
What does a beta coefficient represent?
General: a beta coefficient is a model-based estimate of an association or contrast on the outcome scale, conditional on the model specification. In a randomized comparison, a treatment coefficient may summarize the contrast between assigned groups, but the exact interpretation depends on the terms included in the model and how time and treatment are coded. The registry record calls the target an overall effect estimate among treatment groups, but does not give enough model detail to state the coefficient's precise coding or numerical interpretation. No coefficient is reported for the primary endpoint.
The outcome description identifies the scale's endpoints and direction: 0 is no pain, 10 is pain as severe as one can imagine, and higher scores are worse. This supports interpretation of the scale, but not the clinical importance of any unreported contrast. The registry record does not provide a threshold for a meaningful change or a treatment-effect estimate against which such a threshold could be considered.
Means, standard deviations, and uncertainty
The primary outcome is described as a mean of a continuous measure, with standard deviation as the dispersion measure. General: a mean describes the average score in a group, while a standard deviation describes the spread of individual scores around that average. They answer different questions: the mean concerns the group's typical level on the scale, and the standard deviation concerns variability among observations. Neither alone establishes whether a treatment-group difference is precise or compatible with chance variation. A treatment contrast and an uncertainty measure, such as a confidence interval, are needed to interpret the comparison.
The registry record does not give group means, standard deviations, model coefficients, confidence intervals, or p-values for chronic pain severity. No unadjusted re-calculation can be described from the registry entries. There is also no basis for comparing a registry-reported treatment estimate with a recalculated estimate or for assessing a discrepancy between them.
Why can over-dispersion matter?
General: over-dispersion describes more variability in data than a statistical model's assumptions allow. When a model underestimates variability, standard errors may be too small and confidence intervals too narrow; when variability is represented appropriately, uncertainty estimates are more credible. This concept is relevant in some outcome models, particularly for event counts, but the primary endpoint is continuous and the record describes a linear mixed model. The registry record does not report a diagnostic assessment of dispersion or a correction for it. There is no evidence in the registry record described for this trial that an over-dispersion adjustment was used or required.
How should planning illustrations be understood?
The registry record's planning assumptions describe illustrations based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Such calculations are prospective planning scenarios, not outcomes observed in the trial. They do not measure the probability that the trial's result is correct, and they are not observed power. The listed assumptions alone do not establish the underlying observed effect, the numerical sample size for any scenario, or the trial's original design rationale. A sample-size justification is not reported in the registry record.
General: planning estimates depend on assumptions about the effect to detect, the variability of the outcome, the significance threshold, allocation, and analytic approach. If those assumptions differ from the eventual trial or later study, the planned sample size may not provide the anticipated precision. In this case, the registry record describes the planning framework but does not report a specific sample-size justification or the numerical planning estimates in the registry record for this analysis. These illustrations should therefore be treated only as planning context, separate from the unreported primary results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 4 outcome measures and 2 analyses, but it does not report a multiplicity adjustment, a hierarchy of outcomes, or a testing strategy controlling the chance of false-positive findings across analyses. It is not reported in the registry record whether any such adjustment was planned or applied. Without that information, the status of multiplicity control cannot be established. The primary outcome is identified as chronic pain severity, but the existence of a stated primary outcome does not by itself reveal how other outcomes or analyses were handled statistically.
The record describes the primary-outcome population as all participants who had 3-month pain data available. It does not report how many participants had those data, how many lacked them, or how missing visits were distributed across the treatment groups. The enrollment was 71, but the analyzed primary-outcome count is not reported in the registry record. It is therefore not possible to assess how much information contributed to the primary analysis or whether missing data differed between groups.
The stated mixed-effects analysis concerns repeated measurements. General: methods for incomplete repeated data rely on assumptions about why observations are missing and on the model's specification. Different missing-data patterns or assumptions can affect estimates and uncertainty. The registry record does not report a missing-data method, sensitivity analysis, imputation procedure, or assessment of the assumptions underlying the analysis. It also does not identify whether the primary analysis followed intention-to-treat principles or another analysis population.
These reporting gaps limit interpretation independently of the numerical treatment result: the primary numerical result itself is not reported in the registry record, and the number and handling of available observations are also unclear. No inference should be made about the completeness of follow-up or the analysis population beyond the registry's stated description.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ergocalciferol (Vitamin D2) | 0 | 36 | 0.0% |
| Ergocalciferol Placebo | 0 | 35 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ergocalciferol (Vitamin D2) | 0 of 36 |
| Ergocalciferol Placebo | 0 of 35 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ergocalciferol (Vitamin D2) | 9 of 36 |
| Ergocalciferol Placebo | 6 of 35 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ergocalciferol (Vitamin D2) | Ergocalciferol Placebo |
|---|---|---|---|
| Distressing thoughts related to MVC | Psychiatric disorders | 6 of 36 | 3 of 35 |
| Distressing thoughts related to MVC and depression | Psychiatric disorders | 1 of 36 | 3 of 35 |
| Depression | Psychiatric disorders | 2 of 36 | 0 of 35 |
The registry safety figures list 36 participants at risk in the Ergocalciferol (Vitamin D2) group and 35 in the Ergocalciferol Placebo group. Serious adverse events affected 0 participants in each group, and deaths were 0 in each group. The record also lists other adverse events affecting 9 participants in the Ergocalciferol group and 6 in the placebo group.
These are the posted counts, not a detailed account of each event. The registry record does not report the terms, timing, severity, duration, or relationship to treatment for the other adverse events in the registry record. The serious-event count of 0 in each group means that no affected participants are listed in these registry figures; it does not establish that no event of any kind occurred, nor does it rule out risks that were not captured or reported.
General: safety counts are most informative when interpreted alongside definitions, follow-up duration, and detail about event type and severity. Those details are not reported in the registry record. The figures should therefore be read as limited registry safety summaries rather than as a comprehensive comparison of all possible harms.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel-group phase 2 pilot trial compared a single dose of Ergocalciferol (Vitamin D2) with placebo after MVC. It describes chronic pain severity over 3 months as the primary endpoint and specifies a repeated-measures mixed-model approach. However, it does not report the numerical result of that primary analysis. The treatment effect's direction, size, and precision therefore cannot be determined from the registry record.
The study's stated aim also includes reducing disparity in pain outcomes between Black and White participants. The registry record does not report subgroup estimates or an analysis of whether the treatment contrast differed by race. It is therefore not possible to determine from the posted results whether the disparity objective was met, or even to quantify the disparity in the analyzed population.
The safety data list no serious adverse events and no deaths in either group, alongside the reported counts for other adverse events. These figures describe only what is listed in the registry record; event details are not reported. They do not by themselves establish the full safety profile of either assignment.
The trial is described as a pilot intended to assess feasibility and potential efficacy, with data intended to inform a larger randomized trial. That stated purpose can be distinguished from a definitive conclusion about the effect on pain. General: a small pilot may help identify practical or analytical issues for a subsequent study, but an efficacy conclusion depends on the actual effect estimate, its uncertainty, and the design and analysis details. The registry record does not report the primary numerical findings or the sample-size justification, so it cannot support a conclusion about whether a larger study would confirm a particular effect.
In short, the registry record reports the design, endpoint definition, and some safety counts, but the primary pain result and the disparity analysis are not reported in the registry record. Their absence is not evidence of no effect, no difference, or no disparity. It is a limit on what can be concluded from the posted information.
13. Why This Trial Matters Statistically
This trial is statistically notable for pairing a repeated-measures pain outcome with a stated objective concerning racial disparity. Those are related but distinct questions. An overall treatment contrast addresses whether average pain outcomes differ between assigned groups under the analysis used. A disparity question requires information about outcomes across racial groups, and potentially whether treatment contrasts vary between those groups. The registry record states both aims but does not report numerical results for either the primary pain comparison or the disparity analysis.
The repeated-measures design also makes the analysis more than a comparison of a single score at one point. General: measurements collected from the same participant over time are correlated, so analysis should account for that dependence. The registry record's description of a linear mixed model indicates an approach intended for repeated observations, while the lack of details about model specification, missing data, and estimates limits independent assessment.
The study is explicitly a pilot. Its summary describes feasibility and potential efficacy as aims and says the data can inform an adequately powered larger trial. This is a useful distinction in clinical research: pilot work may help shape a future study, but its role and its statistical precision should not be confused with definitive evidence. The registry record does not report a sample-size justification or numerical primary estimates, so it is not possible to judge the precision of the pain comparison or to relate it to a future trial's design from these registry entries.
Finally, the posted safety counts illustrate why outcome reporting needs context. Serious events and deaths are listed as 0 in both groups, while other adverse-event counts are also reported. Without event descriptions and further follow-up details, these figures are only a limited account. Taken together, the trial's registry entry communicates its central design and measurement strategy, but the absent primary results leave the principal statistical questions unanswered in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this trial from its registry record is that numerical results for chronic pain severity are not reported. Although the endpoint, scale, timeframe, and intended model are described, the treatment-effect estimate, group summaries, confidence interval, and p-value are not reported in the registry record. The direction and precision of the primary comparison cannot therefore be evaluated.
The disparity objective is also not accompanied by reported numerical findings. The record does not provide race-specific outcome summaries, a treatment-by-race estimate, or details sufficient to assess whether the stated disparity question was analyzed. The number of participants with 3-month pain data is not reported, nor are missing-data methods, follow-up completeness, or the primary analysis population beyond the description of participants with available data.
Additional design and analysis details are absent in the registry record described for this trial. The method of sequence generation and allocation concealment, the roles covered by quadruple masking, exact model specification, covariate adjustment, multiplicity strategy, and sample-size justification are not reported in the registry record. These omissions prevent a full assessment of the analysis plan and its assumptions.
The safety report is limited to counts. Descriptions and timing of other adverse events, severity information, and treatment relationship are not reported in the registry record. The trial's pilot purpose and enrollment of 71 also need to be considered alongside the missing primary estimates: without an estimate and uncertainty interval, the precision and implications of the study cannot be judged. These are limitations of the available registry information and do not establish that the underlying study did not collect additional data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vitamin D to ENhance TraUma REcovery — NCT05458024.
- Registry record last updated 2025-03-28; status last verified 2023-05.
- Results first posted 2025-03-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05458024, “Vitamin D to ENhance TraUma REcovery,” is a completed phase 2 randomized, quadruple-masked, parallel-group pilot sponsored by the University of North Carolina, Chapel Hill. Enrollment was 71. The study began on 2023-01-24 and had a primary completion date of 2024-05-01.
Participants were assigned to a single dose of Ergocalciferol (Vitamin D2), 300,000 international units (IUs) in 6 50,000 IU capsules, or an inert placebo in 6 indistinguishable capsules. The primary endpoint was chronic pain severity on a 0-10 scale, assessed over 3 months following MVC and described for analysis with a linear mixed model.
The registry record does not report numerical primary pain results or numerical results for the disparity objective. Safety figures list 0 serious adverse events and 0 deaths in each group; other adverse events are listed for 9 participants in the vitamin D2 group and 6 in the placebo group. The trial summary describes feasibility and potential efficacy as pilot aims.