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 High Dose Vitamin C in the Critically Ill Patient (NCT01587963), a randomized phase 2 study. The primary outcome is Efficacy of High Dose Vitamin C Therapy in Shock Patients.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01587963 |
| Phase | Phase 2 |
| Condition | Shock |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rutgers, The State University of New Jersey |
| Results posted | Yes |
2. Clinical Question
Population
Critically ill patients with shock were the intended population. The registry description refers to septic or hypovolemic shock, while the recorded condition is Shock. The registry record does not report further eligibility details.
Intervention
The intervention was ascorbic acid, described in the study title and summary as high-dose vitamin C. The dose and administration details are not reported in the registry record.
Comparator
The comparison group received Ringers Lactate or Normal Saline. The registry record does not report how the choice between those fluids was made or whether either was used in every participant.
Primary question
The study aimed to assess the efficacy of high-dose vitamin C therapy in patients with shock, with the primary outcome timeframe listed as 30 days. The specific outcome measure and its analysis are not reported in enough detail to quantify a treatment effect.
The clinical question is whether assignment to high-dose ascorbic acid, rather than the listed fluid comparator, was associated with a difference in the planned assessment of efficacy in critically ill patients with shock. The study was randomized and used a parallel-group design, features intended to support a comparison between assigned groups. The registry lists quadruple masking, but does not identify which people involved in the trial were masked or describe how masking was maintained.
The trial’s description gives a rationale based on the poor prognosis of septic and hypovolemic shock and refers to prior investigations in burn patients. That rationale explains why the question was of interest; it does not establish that the treatment is effective in this trial’s population. The registry record states that the study was terminated before data collection was complete and that no data analysis was performed. Consequently, the clinical question remains unanswered by the posted primary results.
3. Trial Design
The registry describes a randomized, parallel-group phase 2 trial with quadruple masking. Participants were assigned to an ascorbic acid group or a group listed as Ringers Lactate or Normal Saline. The intended population was critically ill patients with shock. The registry record does not provide the randomization method, allocation-concealment procedures, masking details, or a full account of the care received alongside the assigned interventions.
Enrollment is recorded as 11. The study began in 2013-02, and primary completion was recorded as 2014-02. Its status is TERMINATED. Most importantly for interpreting the results, the primary outcome description says that the study was terminated before data collection was complete and that no data analysis was performed. Thus, enrollment and design information describe the planned trial, not a completed comparison of clinical outcomes.
The primary outcome is titled “Efficacy of High Dose Vitamin C Therapy in Shock Patients,” with a timeframe of 30 days. However, the registry record does not specify a unit, analysis parameter, or measure of variability for that outcome. It also does not describe how the broad efficacy question was translated into a single endpoint for analysis. A single comparison cannot be reconstructed from the posted information.
The record lists one outcome measure and no analyses. It does not report a sample-size justification, detailed protocol, interim-analysis plan, or complete statistical analysis plan. The planned design therefore cannot be assessed for features such as the intended precision of the primary estimate or the exact rules for analyzing participants. These omissions matter because a design label alone does not describe how a trial was to be analyzed, and the absence of completed analysis means there is no primary treatment-effect estimate to interpret.
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 | Ascorbic Acid | Placebo |
|---|---|---|
| STARTED | 7 | 4 |
| COMPLETED | 6 | 4 |
| NOT COMPLETED | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Study terminated prior to data collection completion. No data analysis performed.
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 | Ascorbic Acid | Ringers Lactate or Normal Saline | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 4 | 11 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 | 3 | 9 |
| Age, Categorical: >=65 years | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Female | Participants | 3 | 3 | 6 |
| Sex: Female, Male: Male | Participants | 4 | 1 | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 3 | 10 |
| 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 | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 5 | 4 | 9 |
| 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 | 7 | 4 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Efficacy of High Dose Vitamin C Therapy in Shock Patients, measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is described as the efficacy of high-dose vitamin C therapy in shock patients, with a timeframe of 30 days. An endpoint is the defined outcome used to evaluate a trial’s principal question. A clearly specified endpoint makes it possible to understand what was measured, when it was measured, and how a comparison between assigned groups should be interpreted.
In this case, the outcome title and description state the broad aim, but do not identify the specific clinical measure, its unit, or its statistical form. The registry record therefore does not clarify whether efficacy was to be assessed as a continuous measure, a categorical outcome, a time-to-event outcome, or another endpoint. The record also does not give a detailed schedule or operational definition for the assessment beyond the 30 days timeframe.
The endpoint matters because different measures capture different aspects of a clinical course and require different interpretations. Without a defined measure and an analysis, readers cannot determine the magnitude or precision of any treatment contrast. The registry states that the trial ended before data collection was complete and no analysis was performed. Accordingly, the posted record describes the intended outcome but does not provide an analyzed primary endpoint result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The most important statistical fact is that the registry reports no completed primary-outcome analysis. The study was terminated before data collection was complete, and the primary outcome description explicitly says no data analysis was performed. There is therefore no posted treatment-effect estimate, confidence interval, or test result for the primary question. The record cannot establish whether the assigned groups differed on the intended efficacy outcome.
Enrollment is recorded as 11, but that figure does not supply an outcome estimate. Nor does the presence of group-level safety counts substitute for an efficacy analysis. The record lists zero serious adverse events among 7 participants at risk in the ascorbic acid group and zero among 4 participants at risk in the Ringers Lactate or Normal Saline group. These entries concern reported safety counts, not the primary efficacy endpoint, and they do not provide a comparison of clinical benefit.
A zero event count in a small group does not prove that the underlying risk is zero. In general, rare events may not appear in a limited set of observations, and uncertainty about the underlying event rate can remain substantial even when no events are recorded. Here, the registry does not provide inferential analyses for the safety counts, and deaths are listed as null rather than as a numeric count. The posted safety information should therefore be read narrowly, as recorded counts and denominators, rather than as evidence that an intervention is safe or unsafe.
Random allocation can help reduce systematic differences between groups, but it does not guarantee that a small trial will produce groups balanced on all relevant characteristics. More importantly, the registry record does not report outcome data or analysis from which the effect of random assignment could be estimated. The design provides context for the intended comparison; it cannot replace the missing results.
The record includes no reported primary-outcome estimate or uncertainty measure, and it does not report a complete account of missing outcomes or analysis populations. Without those details, readers cannot assess the direction, size, or precision of an effect, or judge how incomplete data may have influenced an analysis. The appropriate conclusion is limited: the registry describes a randomized study that was terminated before collection was complete, with no primary analysis reported. It does not answer the efficacy question.
9. Statistical Methods Explained
Randomization assigns participants to trial groups using a chance-based process. In general, this helps make groups comparable at the time of assignment, including with respect to characteristics that investigators did not measure. It does not ensure perfect balance, particularly in a small study, and it cannot correct problems caused by incomplete follow-up or an outcome that was not analyzed. The registry identifies this trial as randomized, but the method used to generate assignments and the method used to conceal them are not reported in the registry record.
A parallel-group design means that assigned groups are followed as separate groups rather than participants crossing through multiple assigned treatments. The record lists ascorbic acid and Ringers Lactate or Normal Saline as the two groups. The record does not report enough detail to determine how the comparator fluid was selected or to reconstruct all treatment procedures. Quadruple masking is recorded, but the identities of the masked parties and the practical masking procedures are not reported in the registry record.
A primary endpoint is the outcome intended to carry the main answer to a trial’s question. Its definition should specify what is measured, the timeframe, and the way the data will be summarized and compared. Here the primary outcome has a 30 days timeframe and a title describing efficacy in shock patients, but its measurement unit and statistical parameter are not specified. The registry record says the primary outcome has several categories or time points and was not reduced to one comparison. That means a single effect estimate cannot be reconstructed from the information recorded.
In general, an effect estimate describes the size and direction of a group contrast, while a confidence interval describes the range of values compatible with the data under the model used. A narrow interval generally indicates greater precision than a wide interval. A confidence interval is not a guarantee that the true effect lies within its limits, and its interpretation depends on the analysis and assumptions. No primary estimate or confidence interval is reported for this trial, so these concepts cannot be applied to quantify its efficacy findings.
Hypothesis tests and p-values are sometimes used to assess how compatible observed data are with a null hypothesis under specified assumptions. A p-value does not measure the size or clinical importance of an effect. It also does not make a result reliable if the outcome data are incomplete or the analysis is not reported. The registry record reports no primary analysis and no primary test result. No significance conclusion can be drawn from the absence of such a result.
Over-dispersion is a general issue that arises when observed variability is greater than a statistical model assumes. If ignored, standard errors and confidence intervals may be too small, making results appear more precise than they are. Whether over-dispersion is relevant depends on the outcome type and model. Because the registry does not specify the primary endpoint’s statistical form or report an analysis, it is not possible to determine whether over-dispersion was relevant or how it would have been handled.
Sample-size planning is different from outcome analysis. A planning calculation illustrates how much information a future study might need under stated assumptions; it is not a result about treatment efficacy. The registry’s planning assumptions describe illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. The record also distinguishes the interpretation of planning outputs for time-to-event outcomes from other outcome types. These are planning conventions, not evidence that this trial had adequate power or that an effect was detected. They should not be described as observed power.
The record does not report a sample-size justification for the trial itself. It also does not report the assumptions used to choose its enrollment target or explain whether recruitment stopped for reasons related to feasibility, safety, or another consideration. Since the study is marked terminated and its primary analysis was not performed, a planning illustration cannot fill the gap left by missing outcome results.
Analysis populations also affect interpretation. For example, an intention-to-treat analysis generally compares participants according to their randomized assignment, while other analysis populations may use different inclusion rules. These approaches answer related but not identical questions, and exclusions after randomization can introduce bias. The registry record does not report the analysis population for the primary endpoint. With no primary analysis reported, readers cannot determine which participants were included or how deviations from assigned treatment would have been handled.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study evaluates multiple outcomes, comparisons, time points, or subgroups. Repeated testing can increase the chance of finding an apparently notable result by chance, so a statistical plan may specify a primary comparison or an adjustment strategy. The registry record lists one outcome measure, but also states that the primary outcome has several categories or time points and was not reduced to one comparison. It does not report a multiplicity-adjustment plan or identify a single analyzed contrast.
The record does not report a completed primary analysis. As a result, there are no posted outcome estimates to evaluate for selective reporting across outcomes or time points. The absence of an analysis does not establish that multiplicity was handled, or that it was not relevant; the analysis plan is not reported in the registry record.
Missing data can affect results when outcomes are not observed for all participants or when missingness is related to health status, treatment, or other factors. Appropriate handling depends on why data are missing and on the planned estimand and analysis. The registry states that data collection was incomplete, but does not report the amount or pattern of missing primary-outcome data, reasons for missingness, or any imputation or sensitivity analyses. Those details are not reported in the registry record.
The record also does not state which analysis population would have been used for the primary outcome, or how participants who stopped treatment or did not complete follow-up would have been handled. These omissions prevent assessment of whether the intended comparison preserved the benefits of randomization or how sensitive any estimate would have been to assumptions about incomplete observations.
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 |
|---|---|---|---|
| Ascorbic Acid | 0 | 7 | 0.0% |
| Ringers Lactate or Normal Saline | 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 |
|---|---|
| Ascorbic Acid | 0 of 7 |
| Ringers Lactate or Normal Saline | 0 of 4 |
The registry reports serious adverse event counts of 0 among 7 participants at risk in the ascorbic acid group and 0 among 4 participants at risk in the Ringers Lactate or Normal Saline group. It also reports other adverse event counts of 0 for each group, using the same group-specific at-risk counts. These are the posted counts and denominators; they are separate from the primary efficacy outcome.
These entries should not be interpreted as proof that serious or other adverse events cannot occur, or as a reliable estimate of comparative safety. In general, when few participants are observed, zero recorded events can coexist with considerable uncertainty about the underlying frequency of an event. The registry does not report uncertainty intervals or a statistical comparison for these counts.
Deaths are listed as null for both groups. A null entry is not a numeric count and should not be read as zero deaths. The registry record also does not provide further detail about adverse-event definitions, collection procedures, or the period covered by the safety counts. Because the study was terminated before data collection was complete, the safety entries should be interpreted as limited registry-reported counts, not as a complete assessment of risk.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group phase 2 study of high-dose vitamin C in critically ill patients with shock was conducted and terminated. It records enrollment as 11 and lists an ascorbic acid group and a Ringers Lactate or Normal Saline group. The primary outcome was intended to address efficacy over a 30 days timeframe.
What the record does not establish is whether high-dose vitamin C improved, worsened, or had no effect on the intended outcome. The study was terminated before data collection was complete, and the registry states that no data analysis was performed. No primary effect estimate, confidence interval, or test result is reported. The direction and size of any treatment effect, and the precision with which it might be estimated, are therefore unknown from this record.
The posted adverse-event counts do not resolve the efficacy question, and their zero counts should not be treated as proof of absence of harm. The death entries are null, not numeric counts. The available safety information is limited and lacks an inferential analysis.
More generally, a trial’s design can describe how investigators intended to compare interventions, but a design description is not a result. Randomization and masking are features of the planned approach; they do not supply missing outcome data. Likewise, planning calculations are not observed power and cannot show that a treatment effect was found.
The findings should not be generalized beyond what the record reports. It does not give enough detail to define the primary clinical measure, assess the completeness of outcome follow-up, or understand the analysis population. The defensible interpretation is that the registry documents an incomplete trial record without a completed primary efficacy analysis. The clinical question remains unresolved in the posted results.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between a randomized design and an interpretable estimate of treatment effect. Randomization is valuable for constructing a fair comparison, but a statistical conclusion still requires a defined endpoint, collected outcome data, and a reported analysis. The registry describes the design but states that collection was incomplete and no analysis was performed.
The case also shows why endpoint specification matters. “Efficacy” is a broad objective, not by itself a measurable variable. The record gives a 30 days timeframe, yet does not specify the outcome’s unit or statistical form and says that multiple categories or time points were not reduced to one comparison. Without a clear estimand and a corresponding analysis, readers cannot identify what a single treatment-effect number would mean.
Safety counts require similar care. Zero recorded events in groups with at-risk counts of 7 and 4 do not establish zero underlying risk. Counts without uncertainty estimates can be especially easy to overinterpret when the trial is small or incomplete. Null death entries also cannot be converted into event counts.
Finally, planning assumptions and trial results answer different questions. A planning illustration can describe requirements under assumptions, but it cannot substitute for observed data or demonstrate observed power. This distinction is important when a trial ends before its intended analysis: the design may have aimed to answer a clinically relevant question, while the available record remains insufficient to do so.
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 central limitation is that the trial was terminated before data collection was complete and no data analysis was performed, according to the primary outcome description. No analyzed efficacy result is available in the registry record. Consequently, neither the size nor the direction nor the precision of a treatment effect can be assessed.
The endpoint is insufficiently specified for independent interpretation. Its title gives a broad efficacy objective and its timeframe is 30 days, but no measurement unit or statistical parameter is recorded. The registry notes that the outcome has several categories or time points and was not reduced to one comparison. The operational definition, assessment schedule, and planned summary measure are not reported in the registry record.
The record does not provide details of eligibility criteria, baseline characteristics, treatment dose, administration procedures, comparator selection, or concomitant care. It also does not identify who was masked, describe allocation concealment, or report the method used to generate random assignments. These missing details limit assessment of how the planned design was implemented.
Information about missing outcomes, analysis populations, protocol deviations, and reasons for termination is not reported in the registry record. A sample-size justification and complete statistical analysis plan are also not reported. The posted safety counts have no accompanying uncertainty analysis, and deaths are recorded as null. Together, these limitations mean that the registry record offers limited descriptive information and no completed primary efficacy analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: High Dose Vitamin C in the Critically Ill Patient — NCT01587963.
- Registry record last updated 2017-05-11; status last verified 2017-03.
- Results first posted 2017-05-11.
- 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 describes a randomized, quadruple-masked, parallel-group phase 2 study of high-dose vitamin C in critically ill patients with shock. The groups were ascorbic acid and Ringers Lactate or Normal Saline. Enrollment is recorded as 11, and the study status is TERMINATED.
The primary outcome concerned efficacy in shock patients over a 30 days timeframe. The record states that the study ended before data collection was complete and that no data analysis was performed. It does not report an analyzed primary treatment effect or a defined single comparison.
Serious adverse event counts are recorded as 0 among 7 participants at risk in the ascorbic acid group and 0 among 4 participants at risk in the comparator group. Deaths are listed as null. These limited safety entries do not answer the efficacy question or establish comparative safety. Overall, the posted registry information documents the trial’s design and incomplete status, but does not provide a primary outcome result.