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 Deficiency and Atopic Dermatitis (NCT01337635), a randomized na study. The primary outcome is Atopic Dermatitis Severity at the Completion of Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01337635 |
| Phase | NA |
| Condition | Atopic Dermatitis, Vitamin D Deficiency |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 7 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Medical College of Wisconsin |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency. Atopic dermatitis is described in the registry record as a chronic skin disease involving a defective skin barrier, inflammation, and increased propensity for skin infections. The primary outcome data include three participants in each treatment group; the registry record does not report further eligibility details for the participants represented in those results.
Intervention
The high-dose group received ergocalciferol 300,000 IU, given as six capsules of 50,000 IU in a single oral dose observed in clinic. The registry record describes the intervention as vitamin D and identifies this arm as high dose. The posted primary outcome is at the six-week study visit.
Comparator
The standard-dose group received cholecalciferol 400 IU daily at home. The trial used randomized allocation and a parallel-group design. Masking is recorded as single, but the registry record does not identify which people were masked or describe how masking was maintained.
Primary question
The primary question was whether atopic dermatitis severity, measured by SCORAD at the six-week study visit, differed between the vitamin D dose groups. SCORAD is scored from 0-103, with higher scores indicating more severe atopic dermatitis. The posted group means are 33.1 for standard dose and 15.5 for high dose. These descriptive results alone do not establish the size or certainty of a treatment effect; no analysis of the comparison is reported in the registry record.
3. Trial Design
The registry record describes a randomized, single-masked, parallel-group trial of vitamin D treatment for atopic dermatitis in participants with vitamin D deficiency. The two arms compared cholecalciferol 400 IU daily at home with a single observed oral dose of ergocalciferol 300,000 IU. The record lists enrollment as 7, while the primary outcome results include three participants in each arm. The registry record does not explain the relationship between the enrollment figure and the number contributing to the primary outcome results.
The primary outcome was atopic dermatitis severity at the completion of treatment, defined as SCORAD at the six-week study visit. The standard-dose group had a reported mean score of 33.1, with a full range of 25.6 to 43.4, among three participants. The high-dose group had a reported mean score of 15.5, with a full range of 3.5 to 30.2, also among three participants. These are descriptive summaries. No comparative estimate, confidence interval, or inferential test is reported in the registry record.
The trial status is recorded as terminated. Its recorded start was 2010-11 and primary completion was 2012-12. The registry record does not report why the trial was terminated, whether planned recruitment was completed, or whether the timing or conduct of the trial changed. It also does not report the allocation procedure beyond randomized allocation, the identity of the masked party, or further details of the treatment protocol. The registered hypothesis anticipated improved cutaneous disease with high-dose rather than standard-dose vitamin D, but a hypothesis is not a trial result.
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.
Overall Study
| Stage | Standard Dose Vitamin D | High Dose Vitamin D |
|---|---|---|
| STARTED | 3 | 4 |
| COMPLETED | 3 | 3 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Standard Dose Vitamin D | High Dose Vitamin D |
|---|---|---|
| Lost to Follow-up | 0 | 1 |
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 | Standard Dose Vitamin D | High Dose Vitamin D | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 4 | 7 | |
| Age, Categorical: <=18 years | Participants | 3 | 4 | 7 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 9 (3 to 15) | 5 (2 to 10) | 6.7 (2 to 15) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 4 |
| Region of Enrollment: United States | participants | 3 | 4 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Atopic Dermatitis Severity at the Completion of Treatment, measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was SCORAD at the six-week study visit. SCORAD, or SCORing Atopic Dermatitis, is a clinical tool used to assess the extent and severity of eczema. The registry record defines its scale as 0-103 and states that higher scores indicate more severe atopic dermatitis, which is a worse outcome. A score therefore provides a measure of disease severity at the specified visit.
The posted results summarize the endpoint as a mean and full range for each group. The standard-dose group mean was 33.1, with a full range of 25.6 to 43.4 among three participants. The high-dose group mean was 15.5, with a full range of 3.5 to 30.2 among three participants. A mean gives a compact description of the group’s observed scores, while the range shows the lowest and highest observed scores. Neither summary by itself describes the precision of a between-group comparison.
Using a clinical severity measure makes the endpoint relevant to the trial’s question about atopic dermatitis. The registry record does not report additional details about the SCORAD assessment process, who performed assessments, or whether the endpoint was analyzed using an adjusted or unadjusted method.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome results describe three participants in each treatment group. The mean SCORAD score was 33.1 in the standard-dose group and 15.5 in the high-dose group. Because higher SCORAD scores indicate more severe atopic dermatitis, the observed mean was lower in the high-dose group. The full range was 25.6 to 43.4 for standard dose and 3.5 to 30.2 for high dose. The ranges overlap, and the small group counts make the descriptive summaries especially sensitive to the scores of individual participants.
These observations do not quantify how precisely the groups differ. The registry record reports no confidence interval, p-value, or analysis of the primary comparison. It also reports zero analysis entries. Without an inferential estimate, the posted means should not be read as evidence that the difference is distinguishable from chance variation or as a precise estimate of the effect in a broader population. No adjusted comparison is reported either.
The registered hypothesis stated that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency would have improved cutaneous disease after high-dose rather than standard-dose vitamin D. The hypothesis gives context for the comparison, but the observed group summaries do not, on their own, confirm or refute it. The registry record’s status is terminated, and the reason for termination is not reported in the registry record. That status is important context when considering the limited number of posted primary outcome observations, but the record does not establish why the study ended or what role, if any, the observed results played.
Enrollment is recorded as 7, while the primary endpoint summaries report three participants in each group. The record does not explain the remaining difference, so the analysis population and handling of any participants without endpoint data are not reported in the registry record. This limits assessment of how representative the posted endpoint summaries are of all enrolled participants. The results should therefore be interpreted as a small set of descriptive observations rather than a conclusive comparison of dose strategies.
The primary endpoint is a severity score at a single specified visit, not a record of the full course of disease. A secondary outcome, time to restart topical steroids, is listed, but no analysis of it is posted. The registry record therefore gives little information about outcomes beyond the six-week SCORAD summaries.
9. Statistical Methods Explained
What does the mean describe?
A mean is the arithmetic average of the observations in a group. In this trial, the posted mean SCORAD score was 33.1 for standard dose and 15.5 for high dose. The mean gives a concise description of the observed scores, but it does not show how much participants varied around that average. The registry record reports the full range, not a standard deviation or another measure of spread around the mean. The observed ranges are 25.6 to 43.4 and 3.5 to 30.2, respectively.
With only three participants contributing to each group summary, an individual score can have a substantial influence on the mean. A lower mean in one group is a descriptive pattern, not by itself a statistical test or a statement about how likely the pattern is to recur. The registry record does not report participant-level data that would permit other summaries of the score distribution.
What does a range show?
A full range gives the lowest and highest observed scores. It describes the span of the observations in the group, but it is not a confidence interval. A confidence interval is a statistical expression of uncertainty around an estimate, based on a specified method and assumptions. The record reports no confidence interval for either group mean or for a comparison between groups. The reported ranges should not be used as if they posted that missing inferential information.
What is needed for a treatment comparison?
A treatment comparison would ordinarily describe the difference between groups using an estimate and its uncertainty, with an analysis method suited to the outcome and design. The registry record does not report a comparative estimate, a test statistic, a p-value, or an adjusted analysis for the primary endpoint. It records zero analyses. Consequently, the means and ranges can be described, but the precision of a treatment contrast cannot be assessed from the posted result alone.
Randomized allocation is intended, in general, to support comparisons by assigning participants to treatment groups through a chance-based process. It does not remove uncertainty when the observed groups are very small, and it does not itself show that the groups are comparable on every characteristic. The record says allocation was randomized, but does not describe the sequence-generation or allocation-concealment procedures. Masking is recorded as single; the masked party and masking procedures are not reported in the registry record.
How should the planning illustration be read?
The trial’s own sample-size justification is not reported in the registry record. A planning illustration based on the observed effect is not evidence about the trial’s achieved statistical power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such calculations are hypothetical planning exercises that depend on their assumptions. They do not change the number of participants actually observed, and they cannot substitute for an analysis of the trial results. No planning values are reported in the registry record from which to describe a particular target number of participants.
For a general explanation, power is the probability that a specified analysis would detect an effect of a defined size under its assumptions. It is not a property that can be inferred from whether a result looks numerically large, and a post hoc calculation based on an observed effect does not establish the reliability of that effect. The posted group sizes are three participants per arm, and the record does not report a prospective sample-size rationale or a target based on a clinically meaningful SCORAD difference.
What does over-dispersion mean in general?
Over-dispersion is a general statistical issue that arises when data vary more than a model assumes. It can make uncertainty estimates from an overly restrictive model misleading. The registry record does not report a model for the SCORAD outcome or evidence about over-dispersion. Because SCORAD is reported as a score with group means and ranges, it would be inappropriate to claim that an over-dispersion adjustment was needed or used.
More broadly, the analysis method, missing-data approach, analysis population, and any covariate adjustment are not reported in the registry record. These details matter because they define which participants and outcomes contribute to an estimate and how uncertainty is calculated. In their absence, interpretation should stay close to the posted descriptive summaries rather than imply an unreported statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one secondary outcome: time to restart topical steroids. It reports two outcome measures and zero analysis entries. The primary endpoint is SCORAD at the six-week study visit. No analysis results for the secondary outcome are posted, and the record does not report whether it was measured, how it was summarized, or whether it was analyzed.
Multiplicity refers, in general, to the increased chance of a misleading finding when several outcomes or comparisons are tested. Statistical plans can address this issue by defining a primary outcome and specifying how secondary analyses will be interpreted or adjusted. The registry record does not report a multiplicity plan, any adjustment for multiple testing, or a prespecified hierarchy among outcomes beyond identifying the primary endpoint. With no analysis entries, there are no posted tests on which to assess multiplicity adjustments.
The primary outcome summaries include three participants in each arm, while overall enrollment is recorded as 7. The registry record does not explain this difference or state whether participants lacked a six-week score, were excluded, or were analyzed under another rule. The number and reasons for missing primary endpoint values are therefore not reported in the registry record. An analysis population, such as all randomized participants or participants with observed endpoint data, is also not specified.
Missing-data methods can affect results when participants do not contribute outcome measurements. For general context, an analysis based only on observed scores describes those with available scores, while methods for handling missing measurements require assumptions about why data are missing. The record does not provide information to assess those assumptions or to determine whether any missing-data procedure was used. The registry record also does not report an interim-analysis plan, so no claim about interim monitoring or its role in the termination status can be made.
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 |
|---|---|---|---|
| Standard Dose Vitamin D | 0 | 3 | 0.0% |
| High Dose Vitamin D | 0 | 4 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Standard Dose Vitamin D | 0 of 3 |
| High Dose Vitamin D | 0 of 4 |
The posted adverse-event figures list three participants at risk for serious adverse events in the standard-dose group, with zero affected, and four at risk in the high-dose group, also with zero affected. For other adverse events, the corresponding figures are three at risk and zero affected in the standard-dose group, and four at risk and zero affected in the high-dose group. These counts describe the registry’s recorded safety results for the listed groups.
Zero reported events in these small groups does not establish that no events could occur or that the treatments have equivalent safety. With few participants, the observed counts provide limited information about uncommon harms or differences between groups. The record does not provide event-level descriptions, follow-up details for safety outcomes, or a statistical comparison of adverse events. The top serious-event terms list is empty.
Deaths are recorded as null for both groups, not as zero. Thus, deaths are not reported in the registry record; a null value should not be interpreted as a confirmed count of zero. Safety figures should be read as counts in the recorded populations, not as a complete characterization of risk.
12. What the Result Does, and Does Not, Mean
The primary endpoint observations show lower mean SCORAD in the high-dose group than in the standard-dose group at the six-week visit. The registry record reports a mean of 15.5 among three high-dose participants and a mean of 33.1 among three standard-dose participants. Given that higher SCORAD indicates worse atopic dermatitis, the direction of these observed means is consistent with the direction anticipated in the registered hypothesis.
That description does not establish that the high-dose regimen caused a reduction in severity, that any difference is statistically distinguishable from chance, or that the observed pattern would apply to other patients. The groups are very small, their observed score ranges overlap, and no estimate of the between-group contrast or its uncertainty is reported. No p-value or adjusted analysis is reported in the registry record. Statistical significance and clinical importance cannot be inferred from the two means alone.
The findings also do not establish the comparative safety of the regimens. The recorded adverse-event counts are zero affected in each group for serious and other adverse events, but only three standard-dose and four high-dose participants are listed at risk. Deaths are not reported in the registry record. Such counts do not characterize uncommon events or resolve safety differences.
The trial is recorded as terminated, but the reason is not reported in the registry record. The record does not explain the difference between total enrollment and the number contributing to the primary endpoint summaries, nor does it provide a missing-data account or analysis-population definition. These gaps limit interpretation of both the scope and the precision of the outcome summaries.
In practical statistical terms, the result is a small descriptive comparison that can motivate questions but cannot provide a precise treatment-effect estimate. The listed secondary outcome has no posted analysis. The record therefore supports a careful account of the observed SCORAD summaries, not a broad conclusion about treatment benefit, lack of benefit, or overall clinical value.
13. Why This Trial Matters Statistically
This trial illustrates why a randomized design and a numerical difference between group means do not automatically yield a dependable estimate of a treatment effect. Randomization is a useful design feature, but the primary summaries include only three participants per arm. With so few observations, the group means and ranges convey what was recorded in those participants, while offering limited information about how results might vary in a larger population.
It also highlights the distinction between a descriptive result and an inferential comparison. The standard-dose mean was 33.1 and the high-dose mean was 15.5, but the registry record reports no confidence interval, p-value, or analysis of the contrast. Readers can describe the observed direction in relation to the SCORAD scale, yet cannot judge the precision of a treatment-effect estimate from these summaries. A sample-size planning illustration, when based on the observed effect, does not retroactively supply that missing precision or demonstrate observed power.
Outcome reporting and accounting for participants are central to interpretation. The enrollment figure is 7, whereas the primary outcome is summarized for three participants in each arm. Without an explanation of who contributed data and how missing outcomes were handled, the scope of the endpoint summaries remains uncertain. Likewise, a listed secondary outcome without a posted analysis cannot answer a question about that outcome.
Finally, the recorded terminated status makes it especially important not to infer why the trial ended. The registry record does not state the reason. Keeping the interpretation close to the posted data—small group summaries, no comparative analysis, and limited safety counts—is a useful discipline when evaluating sparse clinical-trial records.
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 most direct limitation is the small number of participants represented in the primary outcome summaries: three in each group. The means and full ranges are descriptive, and the record provides no confidence interval or comparative statistical analysis. This prevents a direct assessment of the precision of the group contrast. The total enrollment is recorded as 7, but the registry record does not explain why the primary outcome summaries include six participants.
The registry record does not report a sample-size justification, a target enrollment rationale, or the minimum difference in SCORAD considered important. Although planning assumptions for an illustrative calculation are stated, no trial-specific design rationale or planning result is reported. The statistical analysis plan, analysis population, missing-data approach, and any adjustment for participant characteristics are also not reported in the registry record.
Details of randomization and masking are limited. Allocation is recorded as randomized, and masking as single, but the sequence-generation and concealment methods and the identity of the masked party are not reported. The registry record does not give further details of the endpoint assessment procedures or explain whether the registered treatment schedule was followed for every participant.
The study status is terminated, with no reason stated in the registry record. The record does not explain whether recruitment stopped early, whether the planned sample was reached, or whether termination affected outcome collection. It lists time to restart topical steroids as a secondary outcome, but no analysis is posted. Safety summaries are based on small listed groups, and deaths are not reported in the registry record. Together, these limitations mean the posted findings provide a narrow descriptive snapshot rather than a complete account of the trial’s planned and analyzed evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vitamin D Deficiency and Atopic Dermatitis — NCT01337635.
- Registry record last updated 2018-12-05; status last verified 2018-11.
- Results first posted 2015-04-08.
- 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
The registry record describes a randomized, single-masked, parallel-group trial of standard-dose versus high-dose vitamin D for pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency. The primary endpoint was SCORAD at the six-week study visit. The standard-dose group mean was 33.1, with a full range of 25.6 to 43.4 among three participants; the high-dose group mean was 15.5, with a full range of 3.5 to 30.2 among three participants.
The trial is recorded as terminated. No analysis of the primary comparison is reported in the registry record, and the reason for termination, the explanation for the difference between enrollment and endpoint counts, and the missing-data approach are not reported. Safety counts show zero serious and zero other adverse events in the listed groups; deaths are not reported. These results are descriptive and do not provide a precise comparative treatment-effect estimate.