Sunshine 2 Study for Women With Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sunshine 2 Study for Women With Diabetes (NCT01904032), a randomized phase 2 study. The primary outcome is Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort.

2. Clinical Question

3. Trial Design

Sunshine 2 was a completed, randomized, parallel-group phase 2 trial sponsored by Loyola University. The registry records quadruple masking. Participants were assigned to high-dose vitamin D3 or a lower-dose vitamin D3 comparator; therefore, the comparison concerns two doses of the same supplement rather than supplement versus no supplement. The registry lists an enrollment of 265. Its brief summary describes an intended population of approximately 180 adult women with type 2 diabetes and significant depressive symptoms. The registry record does not explain the relationship between that approximate figure and the enrollment field.

The listed start date is 2013-11-21, and the primary completion date is 2017-11-11. The status is completed. The intervention description specifies weekly dosing for six months and describes approximately four in-person study visits and several telephone visits during that period. The registry does not report further details about visit adherence or the timing of each assessment beyond the stated baseline and month 6 timeframe for the outcomes.

The primary outcome was change in CES-D score. The secondary outcomes were change in Problem Areas in Diabetes (PAIDS) score, systolic blood pressure, and diastolic blood pressure, each from baseline to month 6. For the primary analysis, the registry identifies 57 participants in the low-dose group and 62 in the high-dose group who completed the month 6 CES-D assessment. These are endpoint analysis counts, not the overall enrollment. Other endpoint counts and analysis details should be read in relation to each outcome rather than assumed to be identical.

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: Two-hundred sixty-five participants consented to participate in the study. Among these individuals, 136 (51.3%) were not randomized for failing to meet study inclusion criteria (134/136 or 98.5%) or because they withdrew consent prior to randomization (2/136 or 1.5%).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The analysis population includes all women randomized to low dose or high dose therapy and completed the month 6 CES-D assessment.

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.

Population: The baseline analysis population comprises all patients randomized to high dose or lose dose therapy

6. Primary Endpoint

The registry lists the primary outcome as Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort, measured over Baseline and 6 months.

The primary endpoint was change in Center for Epidemiologic Studies Depression (CES-D) score from baseline to month 6. CES-D is a self-report questionnaire about the frequency and severity of depressive symptoms. The registry states that raw scores range from 0 to 60, with higher scores indicating worse mood. Each participant’s change score was defined as the month 6 score minus the baseline score. A negative change therefore denotes a lower score at month 6 than at baseline, while a positive change denotes a higher score.

Change scores provide a way to compare how the measured outcome shifted over the trial period in the two randomized groups. The endpoint is clinically relevant to the trial’s stated focus on depressive symptoms among women with type 2 diabetes, and it is a continuous measure that can be summarized with group means and standard deviations. Those summaries describe average changes and the spread of individual changes; they do not show every participant’s experience. The primary analysis population was restricted to randomized women who completed the month 6 CES-D assessment. The registry does not report the outcome values for participants who did not complete that assessment or explain how their missing measurements were handled.

7. Results Posted in the Registry

• High Dose: mean -12.50 versus -13.30 on control; difference 0.80 (95% CI -3.20 to 4.80), standardized effect d = 0.07; z-test p = 0.696.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • High Dose: mean -13.27 versus -13.22 on control; difference -0.04 (95% CI -7.16 to 7.07), standardized effect d = -0.00; z-test p = 0.991.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between High Dose and the control. The interval gives the range of effects that remain compatible with the data.

Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • High Dose: mean -1.66 versus -2.16 on control; difference 0.50 (95% CI -5.69 to 6.68), standardized effect d = 0.03; z-test p = 0.875.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between High Dose and the control. The interval gives the range of effects that remain compatible with the data.

Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • High Dose: mean 0.76 versus -0.75 on control; difference 1.51 (95% CI -2.16 to 5.18), standardized effect d = 0.15; z-test p = 0.419.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between High Dose and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover diabetes-related distress and two blood-pressure measures. Across those endpoints, the posted group mean changes and recalculated comparisons do not present a consistent pattern of clearly separated group averages. The intervals for the recalculated comparisons include zero, and the results should be read as uncertain estimates rather than firm evidence of a difference or equality. The individual endpoint values are listed with their respective results and need not be repeated to understand the overall pattern.

This broad pattern is compatible with the primary result in the limited sense that none of the posted comparisons supplies a sharply precise between-group estimate. The outcomes measure different constructs, however, so similarity in their statistical pattern does not establish a common biological or clinical explanation. Blood pressure and diabetes-related distress should not be treated as substitutes for the primary CES-D measure, and their results do not confirm or overturn the primary comparison.

There are three posted secondary outcomes in addition to the primary endpoint. When several outcomes are tested, unadjusted p-values do not account for the number of opportunities to observe a result that appears notable by chance. The registry record does not report a multiplicity adjustment or a prespecified strategy for interpreting the outcomes as a family. This makes the secondary findings less conclusive than a single prespecified primary test and supports treating them as supportive or exploratory evidence rather than independent confirmation.

The registry identifies all three secondary measures at baseline and month 6. It does not report additional time points or a formal ranking among the secondary endpoints. The available results therefore describe the listed six-month comparisons only. Their uncertainty, the multiple-outcome context, and the absence of a reported multiplicity plan all matter when judging how much weight to place on them.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
• Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
• Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports a two-sided t-test for the primary comparison, with the analysis parameter described as a mean difference in final values. The endpoint description, in contrast, defines the primary outcome as a change score from baseline to month 6. The record does not explain this wording difference or state whether any baseline adjustment was used. The statistical result should therefore be understood according to the method and endpoint descriptions as they are recorded, without assuming an unreported model.

What a mean difference represents

A mean difference compares the average outcome in one group with the average outcome in another. For the recalculated primary comparison, the direction is high dose minus low dose. A value of zero would correspond to equal group means on the analyzed measure. A positive or negative value indicates the direction of the observed difference according to that subtraction order. This is a group-level summary; it is not a description of the change for every individual participant.

The group means are accompanied by standard deviations. A standard deviation describes how spread out participant-level values are around their group mean. It is not the uncertainty interval for the group mean and is not interchangeable with a standard error. The registry lists standard deviations for the primary endpoint of 10.23 in the low-dose group and 12.01 in the high-dose group. Such spread matters because a mean difference estimated from more variable observations is generally less precise than one estimated from less variable observations, all else being equal. This is a general statistical explanation, not a claim about an unreported feature of the trial’s design.

What the confidence interval adds

A confidence interval gives a range of estimates compatible with the observed data under the method used to construct it. Its width conveys precision: a narrower interval indicates greater precision, while a wider interval indicates greater uncertainty. The recalculated interval for the primary comparison runs from -3.2 to 4.796. Since it crosses zero, it includes the possibility of no mean difference as well as differences in either direction. It does not mean that there is a stated probability that the true value lies in this particular interval. The formal interpretation depends on the repeated-sampling properties of the method.

How to read the p-value

The unadjusted p-value for the recalculated primary comparison is 0.696. In general, a p-value measures how unusual the test result would be under a specified null hypothesis and the assumptions of the test. It is not the probability that the null hypothesis is true, and it is not a measure of the size or clinical importance of a difference. A large p-value does not prove equality. The confidence interval and the estimated group means are needed to understand the direction and precision of the observed comparison.

The word “unadjusted” indicates that the recalculated p-value has not been corrected for testing multiple outcomes or comparisons. The registry record does not report whether a multiplicity procedure was planned or applied. The sponsor’s reported primary analysis is listed separately, and its p-value is not identical to the recalculated value. A simple calculation from summary statistics may differ from the sponsor’s result because the registry does not give enough detail to establish that both analyses use identical data handling or inferential procedures.

What the recalculation can and cannot reproduce

The recalculated summaries are simple, unadjusted comparisons based on the group means, standard deviations, and analysis counts posted for each outcome. They are useful for interpreting the posted group summaries and for comparing the broad direction and scale of results. They do not substitute for individual-participant data or establish whether the trial’s reported analysis included additional adjustments. The registry identifies the sponsor’s primary method as a two-sided t-test, but fuller statistical-plan details are not reported in the registry record.

For continuous outcomes, the reported mean and standard deviation summarize the distribution using its center and spread. These summaries can be informative, but they do not show distribution shape, outliers, or whether test assumptions were checked. The registry does not report diagnostic checks, transformations, robust methods, or alternative analyses. A t-test is a general method for comparing means; its usual inference depends on assumptions about the observations and the behavior of the sampling distribution. The available summaries alone cannot verify those assumptions.

The same broad principles apply to the three secondary continuous outcomes. Each has a mean change and a between-group comparison, while the primary outcome remains the designated main question. When several outcomes are examined, the chance of at least one apparently notable result can increase if each is assessed without accounting for the full set. This is why secondary findings, especially unadjusted ones, generally warrant more cautious interpretation. The registry does not report a hierarchy or multiplicity strategy.

11. Confidence Intervals and Precision

The primary comparison’s recalculated 95% confidence interval runs from -3.2 to 4.796 CES-D units. It crosses zero and includes estimates in both directions. The interval therefore does not identify a single direction with high precision. Its breadth is substantial relative to the small difference between the posted group means, indicating that the data are compatible with a range of possible between-group differences rather than narrowly pinning down one value.

Confidence intervals express uncertainty in the estimated group contrast, not the range containing most participants’ individual changes. The standard deviations, 10.23 for low dose and 12.01 for high dose, describe variation among analyzed participants. The confidence interval instead concerns the estimated difference in group means. These measures answer different questions and should not be interchanged.

The interval’s inclusion of zero is consistent with the recalculated unadjusted p-value of 0.696. Neither statistic establishes that the dose groups have exactly equal mean changes. Rather, the evidence does not estimate the between-group contrast precisely enough to exclude zero under the stated comparison. The registry’s own interval is close but not identical to the recalculated interval, so the two should be kept distinct rather than treated as the same calculation.

Precision is also conditional on the analyzed population and the method used. The endpoint analysis included randomized women who completed the month 6 CES-D assessment. The registry does not report how missing assessments were addressed, so the interval does not by itself resolve uncertainty about outcomes for participants without that assessment. It is a measure of sampling uncertainty for the analysis as posted, not a guarantee about other populations, follow-up periods, or treatment comparisons.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size display is a planning illustration based on the observed effect, not the trial’s original design assumptions. Its figures are participants per arm for these continuous outcomes; it does not report total event counts. The listed planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The original sample-size justification and design assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a planned test to have an 80% chance of detecting the specified effect under the planning assumptions, if that effect and the model assumptions hold. The 90% column makes the corresponding illustration for a 90% chance. These are design-planning quantities, not probabilities that the observed trial result is correct. They do not indicate the probability that a particular finding is real, and they are not observed power.

For the primary endpoint, the illustration based on 100% of the observed effect gives 3,087 participants per arm for 80% power and 4,132 participants per arm for 90% power. The rows for 75% and 50% of the observed effect require larger figures: 5,487 and 12,345 participants per arm for 80% power, respectively. The corresponding 90% figures are 7,346 and 16,527 participants per arm. This pattern reflects a general planning principle: smaller target effects are harder to distinguish from random variation and require more participants for the same planned power, all else being equal. Because the observed effect is the basis for these illustrations, they should be read as sensitivity analyses around that estimate, not as a retrospective judgment of the trial’s design.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.798; pooled standard deviation σ = 11.192.
2. n = 2 × (1.96 + 0.842)² × 11.192² / 0.798² = 3,086.2, rounded up to 3,087 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.7982                      # observed difference in means
sigma <- 11.1919751355584                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1904032)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 3,087 (80% power), 4,132 (90% power)
 75% of observed effect: n per arm = 5,487 (80% power), 7,346 (90% power)
 50% of observed effect: n per arm = 12,345 (80% power), 16,527 (90% power)
power.t.test: 3087.2 
Simulated power at n = 3,087 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry’s own primary analysis is described as a two-sided t-test comparing mean final values and is reported as a superiority analysis. The simple recalculation uses the posted group summaries and makes an unadjusted comparison. The two point estimates are numerically aligned, while their reported confidence intervals and p-values are not identical. The registry does not provide enough detail to determine the precise source of that small difference, so the recalculated result should not be presented as a replacement for the sponsor’s analysis.

The sponsor’s reported analysis is the primary registry result. The recalculation is an independent summary-statistic check that helps readers see how the posted group means relate to the between-group contrast. It does not reproduce unreported analytic choices or resolve the registry’s difference in phrasing between a change-score endpoint and an analysis parameter described as final values. The record does not state whether baseline adjustment or other covariate adjustment was part of the reported test.

Both presentations support a cautious reading: the estimated contrast is small relative to the uncertainty interval, and the interval includes zero. Because the analysis details are limited, the two results should be reported separately and their slight numerical differences acknowledged rather than reconciled by speculation. The sponsor’s result remains the reported trial analysis; the recalculation is supplementary and unadjusted.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and three secondary outcomes, with four outcome measures and four analyses posted. The record does not report whether the study used a family-wise error procedure, a false-discovery procedure, a hierarchical testing plan, or another strategy to address multiplicity. It also does not state whether any secondary outcomes were designated as exploratory. Without that information, the unadjusted results should not be interpreted as though the possibility of multiple testing had been addressed.

Multiplicity matters because testing several hypotheses creates more opportunities for a result to appear unusual even when there is no true difference. This is a general statistical concern, not evidence that any particular finding in this trial is false. The primary endpoint should remain distinct from the secondary outcomes, and unadjusted secondary p-values should carry less inferential weight when no correction or hierarchy is reported.

The primary analysis population included randomized women who completed the month 6 CES-D assessment. The record does not describe the number or characteristics of participants without that assessment, the reasons for missing measurements, or a strategy for handling missing outcome data. It does not report imputation, sensitivity analyses, or a missing-data model. Consequently, the analysis population definition is clear, but the potential impact of incomplete follow-up cannot be evaluated from the registry record alone.

The registry does not report whether analyses were based on intention to treat, a modified intention-to-treat population, or another named population. It describes the primary analysis population by randomization and completion of the month 6 assessment. This should not be relabeled as a full intention-to-treat analysis without additional documentation. The record also does not provide a statistical analysis plan, details of protocol deviations, or interim-analysis information. Those items are not reported in the registry record, and no assumptions about them are warranted.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: severe abdominal pain (1.6%), laparoscopic cholecystectomy (1.6%), hiatal hernia (1.6%), cancer diagnosis (1.6%), right total knee replacement (1.6%).

The registry lists serious adverse events among 64 participants at risk in the low-dose group and 65 participants at risk in the high-dose group. Serious adverse events affected 5 participants in the low-dose group and 7 in the high-dose group. The record lists 0 deaths in each group. These figures describe the recorded serious-event counts in the stated groups; they are not, by themselves, a complete comparison of event timing, duration, severity, or attribution.

The registry also lists several serious-event terms with percentages, including severe abdominal pain, laparoscopic cholecystectomy, hiatal hernia, cancer diagnosis, right total knee replacement, and right-sided weakness. These entries should be read as reported event terms rather than as evidence that the supplement caused them. The registry summary does not establish causal attribution for individual events, and the listed terms do not encompass every aspect of safety assessment.

Counts are most informative when read with the number at risk and the study’s follow-up context. Differences in counts alone do not establish a safety difference, particularly without a reported analysis of uncertainty or attribution. No medical advice or causal conclusion follows from these descriptive registry figures.

17. What the Result Does, and Does Not, Mean

The posted primary data describe mean CES-D changes in two randomized groups receiving different weekly doses of vitamin D3 over six months. Both group means were negative, and the recalculated between-group confidence interval includes zero. The result is therefore an uncertain estimate of the difference between the high-dose and low-dose groups, not a precise demonstration that their average changes differed. It also does not establish that the groups were exactly equivalent.

The comparison is between 50,000 international units weekly and 5,000 international units weekly. It is not a comparison with no vitamin D3, so the data do not directly estimate the effect of supplementation versus no supplementation. The result is limited to the trial’s analyzed population of women with type 2 diabetes who completed the month 6 CES-D assessment, as specified in the registry. The registry does not report enough information to assess how incomplete month 6 follow-up may affect the interpretation.

The secondary outcomes add information about diabetes-related distress and blood pressure, but their unadjusted status and the number of outcomes limit the strength of conclusions that can be drawn from them. The registry does not report a plan for multiplicity or a hierarchy among these endpoints. Their estimates should therefore be considered alongside, rather than as replacements for, the primary comparison.

These results do not establish effects beyond the six-month period, in populations not described by the trial, or for treatment comparisons that were not studied. They also do not establish individual response: a group mean cannot predict the course of any one participant. The most defensible reading is descriptive and statistical: the registry reports a primary estimate with substantial uncertainty and secondary results that likewise require cautious interpretation.

18. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison needs to be read through both its estimate and its uncertainty. The group averages show change over time within each dose group, but the central question is the contrast between those changes. A confidence interval spanning zero communicates that the posted data do not narrowly determine the direction of that contrast. Looking only at whether each group’s mean moved from baseline would not answer the between-group question.

It also demonstrates the importance of identifying the comparator correctly. The comparison is between two weekly doses, not between vitamin D3 and a placebo-only or untreated group. The estimand is therefore a difference between dose groups for the analyzed participants, and conclusions should remain attached to that comparison. This distinction is essential when readers translate a trial result into a broader claim.

The registry presents both a sponsor analysis and enough group summaries for a simple recalculation. Their close alignment in the point estimate, alongside small differences in uncertainty statistics, makes clear that recalculation is a check rather than a substitute for the trial’s reported analysis. It also highlights the value of a complete statistical analysis plan: details about baseline handling, missing data, and multiplicity would help readers understand precisely how the reported result was obtained.

Finally, the planning illustrations underscore a general relationship between effect size, uncertainty, and sample size. A smaller effect requires more participants to achieve the same planned power under the stated assumptions. These illustrations are not the trial’s original design justification and do not measure retrospective power. Together, these issues make the trial useful for statistical reading: it distinguishes observed group changes from comparative effects, precision from statistical significance, and planning calculations from trial results.

19. 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 primary analysis population is limited to randomized participants who completed the month 6 CES-D assessment. Although the registry lists overall enrollment and endpoint-specific analysis counts, it does not report details about participants without a completed assessment, reasons for noncompletion, or how missing data were handled. The potential effect of this restriction on the estimated contrast cannot be determined from the registry record.

The comparator received 5,000 international units of vitamin D3 weekly, so the trial does not provide a direct comparison with no supplement. The planned follow-up period was six months, and the registry does not report longer-term outcomes for these endpoints. The population described is adult women with type 2 diabetes and significant depressive symptoms; the posted results do not establish how they apply to other populations.

The registry records a phase 2 trial and lists an enrollment of 265, while the primary endpoint analysis includes the stated completion-based population. The record does not explain the relationship between the brief summary’s approximate enrollment description and the enrollment field. It also does not report the original sample-size justification, a full statistical analysis plan, interim analyses, multiplicity handling, or sensitivity analyses. These omissions limit assessment of design assumptions and robustness.

The primary endpoint description is based on change from baseline, while the reported analysis parameter is described as mean difference in final values. The registry does not clarify whether this reflects a wording choice or a difference in analysis. The recalculation uses posted summary statistics and cannot resolve the ambiguity or check assumptions using participant-level data. Finally, the registry’s adverse-event counts are descriptive and do not alone establish causation or a comparative safety effect.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Sunshine 2 Study for Women With Diabetes — NCT01904032.
• Registry record last updated 2022-04-26; status last verified 2022-03.
• Results first posted 2022-03-31.
• 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.

23. Record Summary

NCT01904032, titled Sunshine 2 Study for Women With Diabetes, is recorded as a completed, randomized, quadruple-masked, parallel-group phase 2 trial sponsored by Loyola University. It compared weekly vitamin D3 at 50,000 international units with an active comparator of 5,000 international units over six months. The registry lists 265 participants enrolled.

The primary endpoint was change in CES-D score from baseline to month 6. The primary analysis included randomized women who completed that assessment. The recalculated comparison has a 95% confidence interval from -3.2 to 4.796 and an unadjusted p-value of 0.696. The interval includes zero and indicates uncertainty about the direction and size of the mean difference.

Three secondary outcomes addressed diabetes-related distress and blood pressure. Their results should be interpreted cautiously because the registry does not report a multiplicity plan. Missing-data methods, the trial’s original sample-size justification, and further details of the statistical plan are not reported in the registry record.