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 Immuno-nutrition Supplementation in Haemodialysis (NCT05700851), a na na study. The primary outcome is C Reactive Protein - Marker of Systemic Inflammation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05700851 |
| Phase | NA |
| Condition | Chronic Kidney Disease Requiring Chronic Dialysis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Nottingham |
| Results posted | Yes |
2. Clinical Question
Population
People with chronic kidney disease requiring chronic dialysis. The registry describes a pilot study involving 17 participants; the safety record lists 16 participants at risk for adverse events.
Intervention
An immuno-nutrition supplement. Participants were advised to take one sachet daily, dissolved in water, and were to be followed for 6 weeks. Individualised dietetic advice is also mentioned, although its full description is not reported in the registry record.
Comparator
There was no separate comparator group. This was a single-group study, and allocation is listed as not applicable. The record therefore does not describe a randomized, like-for-like comparison.
Primary question
The study aimed to assess systemic inflammation using C-reactive protein (CRP) at 6 weeks. The endpoint is described as a median with an inter-quartile range, measured in mg/L using a high-sensitive laboratory test. The CRP result is not reported in the registry record.
The study’s stated purpose was to explore the supplement’s effect on inflammation in people receiving haemodialysis and inform the possibility of future research. The registry lists skeletal muscle mass, energy intake, protein intake, and handgrip strength as secondary outcomes. It does not report results for these outcomes, the timing of their assessments, or the methods used to analyse them.
Because there is no concurrent control group, the study can describe outcomes among participants receiving the intervention but cannot, by itself, separate an intervention-related change from other explanations. For example, changes over time could reflect background variation or changes in care. The registry record does not report a comparison that addresses those possibilities.
3. Trial Design
This is a completed pilot study registered as NCT05700851, with the title Immuno-nutrition Supplementation in Haemodialysis. The official title describes a study of immuno-nutrition and systemic inflammation in people receiving haemodialysis. The sponsor is the University of Nottingham. The study is listed as having a single-group model, with allocation and phase recorded as not applicable and masking recorded as none.
The registry lists an enrollment of 17 and the condition as chronic kidney disease requiring chronic dialysis. The recorded study start date is 2022-09-27, and the primary completion date is 2022-12-09. Its status is completed. These administrative details do not establish how many participants contributed data to each endpoint; endpoint-specific analysis populations are not reported in the registry record.
Participants in the immuno-nutrition group were advised to take one 74 g sachet of the supplement daily, dissolved in 125 ml of water, and to be followed for 6 weeks. Individualised dietetic advice based on patient needs and food preferences is also described, but the complete account of that advice is not reported in the registry record. The record does not describe a separate usual-care or placebo group.
The primary outcome is CRP at 6 weeks, expressed as a median and inter-quartile range in mg/L. The secondary outcomes named in the record are skeletal muscle mass, energy intake, protein intake, and handgrip strength. Seven outcome measures are listed in total, but the registry record does not report the additional measures in the information available for this study.
The record lists no statistical analyses. It does not report the protocol’s sample-size justification, an analysis plan, interim analyses, or a planned method for comparing measurements over time. The study’s pilot designation and single-group structure should therefore frame interpretation: this is not a randomized comparative estimate of an intervention effect.
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 | Immuno-nutrition |
|---|---|
| STARTED | 17 |
| COMPLETED | 14 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Immuno-nutrition |
|---|---|
| Received a kidney transplant | 1 |
| Hospitalisation before starting baseline assessments | 1 |
| Withdrawal by Subject | 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 | Immuno-nutrition |
|---|---|---|
| Participants analysed | 14 | |
| Age, Continuous | years | 69 (SD 13) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 12 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| C reactive protein | mg/L | 7.6 (4.8 to 32.3) |
| Interleukin-6 | pg/mL | 15.3 (7.0 to 22.4) |
| Interleukin-8 | pg/mL | 7.0 (2.4 to 9.5) |
| Handgrip strength | kg | 23.8 (17.1 to 27.9) |
| Skeletal muscle mass | kg | 26.7 (25.3 to 33.6) |
| Energy intake | kcal/kg of body weight/day | 26.6 (22.5 to 33.8) |
| Protein intake | g/kg of body weight/day | 1.0 (0.9 to 1.3) |
6. Primary Endpoint
The registry lists the primary outcome as C Reactive Protein - Marker of Systemic Inflammation, measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | mg/L |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is C-reactive protein (CRP), a blood marker used to assess systemic inflammation. The registry describes a high-sensitive laboratory test and specifies measurement in mg/L at 6 weeks. CRP is used in clinical research because it provides a measurable indicator of inflammatory activity; it is a marker rather than a direct measure of every process involved in inflammation or of a participant’s overall health.
The planned summary is the median with an inter-quartile range. In general, the median indicates the midpoint of the observed values after they are ordered. The inter-quartile range describes the spread of the central portion of those values. These summaries can be informative when measurements are unevenly distributed or influenced by unusually high or low observations. They do not, on their own, show how values changed from baseline or how an intervention compares with another treatment.
The registry record does not report a CRP value, an inter-quartile range, a baseline measurement, or a change estimate. It also does not report the number of participants whose CRP contributed to the endpoint summary. Consequently, the endpoint definition can be described, but its observed distribution and precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the question and measurement schedule but does not report the primary CRP result. It lists CRP at 6 weeks as the primary outcome and specifies that it is to be summarized by a median and inter-quartile range. Without those values, the magnitude and spread of CRP measurements at the endpoint cannot be described. No result should be inferred from the study’s completion status or from its stated purpose.
The design also limits what any endpoint summary could establish. All participants were assigned to a single group, and the record does not identify a concurrent control group. A value measured at 6 weeks would describe the participants measured at that time; without a reported baseline comparison, it would not show how CRP changed during follow-up. Even if a before-and-after comparison were reported, change within one group would not by itself establish that the supplement caused the change. Natural fluctuation, concurrent care, or other changes over time could also be relevant.
The registry lists 17 participants enrolled, while the adverse-event record lists 16 participants at risk. Those figures refer to different record fields, and the reason for the difference is not reported in the registry record. The enrollment count should not be treated as the number with complete CRP data. The endpoint-specific denominator and the handling of missing measurements are not reported.
The registry lists seven outcome measures and zero statistical analyses. It names four secondary outcomes but does not report their values or describe analysis methods. It is therefore not possible to assess whether the endpoint findings were consistent across outcomes, whether results were adjusted for multiple testing, or whether any planned analyses were changed.
The record describes a planning illustration based on a fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. That illustration is not the study’s design: this study is single-group. The illustration’s numerical outputs and the observed effect it refers to are not reported in the registry record. Such planning figures, when available, are not observed power and should not be read as evidence that the trial had a particular probability of detecting an effect.
Overall, the public record supports a description of the pilot’s question, design, intervention, and planned endpoint, but not a quantitative interpretation of clinical outcomes. The absence of reported results is not evidence that an outcome did or did not change. It means that the estimate, its uncertainty, and the analysis population are not available in the registry record.
9. Statistical Methods Explained
The registry identifies a single-group pilot study and a primary endpoint but lists no statistical analyses. That distinction matters: a study description tells readers what investigators planned to measure, while an analysis report explains how collected data were summarized and how uncertainty was assessed. The record does not report the statistical plan, so the methods below explain relevant concepts generally rather than describe analyses known to have been performed.
What does a median and inter-quartile range convey?
In general, a median is the central observation in an ordered set of measurements. It is less affected by extreme observations than the arithmetic mean. The inter-quartile range describes the dispersion of the central portion of the measurements. Together, these summaries give a sense of a typical value and the spread around it, but they do not show every feature of a distribution. They also do not provide a confidence interval or a formal test of a change.
For this study, the registry specifies a median and inter-quartile range for CRP in mg/L at 6 weeks. It does not report either statistic. A reader therefore cannot assess the observed CRP level, the variability among participants, or the precision of an estimate. No confidence interval is listed in the registry record.
What would a confidence interval mean?
Generally, a confidence interval expresses uncertainty around an estimated quantity under a particular statistical model and sampling procedure. A narrower interval indicates greater precision under those assumptions, while a wider interval indicates less precision. A confidence interval is not a guarantee that an individual participant’s measurement lies within its bounds, and it does not by itself address bias from the study design. The registry record does not report a confidence interval for CRP or for another outcome.
Why does the single-group design matter?
In general, a group observed at one follow-up time can provide a description of outcomes in that group, but it does not supply a concurrent control for changes that might have occurred without the intervention. A within-person comparison could account for some stable differences between participants if repeated measurements were collected and analysed appropriately. However, the registry record does not report a baseline CRP value or a statistical method for comparing baseline and follow-up measurements. It is not possible to say whether such a comparison was conducted.
Random allocation to comparison groups can help balance factors between groups, on average, but this study’s allocation is listed as not applicable and the model is single-group. The record therefore does not support an interpretation as a randomized treatment-effect estimate. Masking is listed as none, but the registry record does not describe how outcome measurement or other procedures were conducted in practice.
What does the planning illustration represent?
In general, a sample-size calculation estimates how many observations might be needed to detect a specified effect under chosen assumptions. Its output depends on the effect size, significance level, allocation, variability assumptions, and statistical method. It is a planning tool, not a finding about participants’ outcomes and not a measure of the probability that a completed study detected an effect.
The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and detecting a stated fraction of the observed effect. Those assumptions describe a hypothetical two-arm calculation rather than this single-group study. The numerical planning outputs and the observed effect used for them are not reported in the registry record. Any such illustration should be read as a planning scenario, not as the trial’s design, an observed result, or observed power.
Over-dispersion is a general concern when outcome variability is larger than a statistical model assumes. If variability is underestimated, uncertainty can be understated and intervals may be too narrow. The registry does not report the model used for any outcome analysis, a dispersion assessment, or an adjustment for it; therefore, no claim about over-dispersion in this study is possible.
What can be inferred from the analysis record?
The registry lists seven outcome measures and zero analyses. This does not establish that no analyses were done outside the registry; it means that statistical analyses are not reported in the registry record. The record also does not state whether estimates were adjusted for baseline characteristics, how repeated measures were handled, or whether data distributions were assessed before choosing summaries or tests. Without the analysis methods and numerical results, readers cannot evaluate model fit, assumptions, uncertainty, or the effect of analytic choices.
These method distinctions help keep the interpretation proportional to the evidence available. The endpoint definition and study structure are reported, but the numerical findings and inferential methods are not. General statistical principles can clarify what would be needed for interpretation, but they cannot substitute for the missing results or analysis description.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, including CRP as the primary outcome and skeletal muscle mass, energy intake, protein intake, and handgrip strength among the secondary outcomes. It does not report the remaining outcome measures in the information available for this study. It also lists zero statistical analyses. The record therefore does not identify which outcomes were analysed, which results were considered primary in practice, or whether any prespecified analysis hierarchy was followed.
In general, testing or estimating many outcomes can increase the chance that at least one result appears notable by chance. Statistical approaches can address this issue, but the appropriate approach depends on the research question and analysis plan. Adjustment for multiplicity, prioritization of outcomes, or other strategies are not reported in the registry record. It would be inappropriate to assume that an adjustment was or was not used.
Missing-data methods are also not reported. The registry does not give the number of participants with primary endpoint data, reasons for missing measurements, or procedures for handling missing values. The enrollment of 17 does not establish that all enrolled participants contributed to every outcome. The safety record’s 16 participants at risk is a separate count, and the reason it differs from the enrollment figure is not reported.
The analysis population is not reported in the registry record. There is no description of whether analyses included all enrolled participants, only those who completed follow-up, or another defined group. The record also does not state whether protocol deviations or adherence were considered in an analysis. These omissions limit assessment of representativeness and the potential influence of missing or excluded 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 |
|---|---|---|---|
| Immuno-nutrition | 0 | 16 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Immuno-nutrition | 0 of 16 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Immuno-nutrition | 1 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Immuno-nutrition |
|---|---|---|
| Intolerance to the immuno-nutrition supplement | Gastrointestinal disorders | 1 of 16 |
The safety record lists 16 participants at risk in the immuno-nutrition group. It reports zero participants affected by serious adverse events, one participant affected by other adverse events, and zero deaths. These are registry counts; they do not establish the nature, timing, severity, duration, or relatedness of the other adverse event.
Zero serious adverse events recorded should be read as a description of the registry entry, not as proof that serious harms are impossible or that no event occurred outside the record’s reporting definitions. The registry does not list serious adverse-event terms. It also does not report a detailed safety narrative, the criteria used to classify events, or whether events were judged related to the supplement.
The count of 16 participants at risk is not the same as the enrollment of 17, and the reason for the difference is not reported in the registry record. Counts alone do not convey the duration or completeness of safety monitoring, beyond the six-week follow-up described for the intervention. No rates or comparative safety estimates are reported, and there is no separate control group against which to compare these figures.
12. What the Result Does, and Does Not, Mean
This record describes a completed pilot study that aimed to examine systemic inflammation among people receiving haemodialysis after use of an immuno-nutrition supplement. It specifies CRP at 6 weeks as the primary endpoint, with a median and inter-quartile range as the planned summary. It also lists several nutritional and physical-function outcomes. These details clarify the study question and the kind of measurements intended.
The registry record does not report numerical outcome results or statistical analyses. As a result, it does not establish the observed CRP level, whether CRP changed from baseline, how variable the measurements were, or how precisely an effect could be estimated. It also does not report results for the secondary outcomes. A completed status indicates the record’s administrative status; it is not itself evidence of a particular outcome.
The design is single-group, without a concurrent control. Even if a change in CRP were available, a change over time in one group would not alone show that the intervention caused it. A comparison group and a clearly reported analysis could help address alternative explanations, but neither is described as part of this study’s design.
The safety entry reports no serious adverse events among 16 participants at risk, one participant with another adverse event, and no deaths. These counts are limited to the registry’s reported categories and do not provide detailed descriptions or comparative estimates.
The study can therefore be understood as a pilot intended to inform future research, not as a definitive comparative test. Its record documents the population, intervention, endpoint, and selected safety counts, while leaving the outcome estimates, analysis methods, missing-data handling, and endpoint-specific participant numbers unreported. Neither positive nor negative conclusions about the supplement’s effect on inflammation can be drawn from the information in the registry record.
13. Why This Trial Matters Statistically
Pilot studies can be useful for developing a research question and identifying practical considerations for later research. This study focuses on systemic inflammation in people receiving haemodialysis and identifies CRP as its primary endpoint. It also includes measures related to muscle mass, dietary intake, and handgrip strength. The combination indicates a research interest in both inflammation and nutritional or physical measures, while the registry record does not report results for those outcomes.
The design makes the distinction between description and causal inference especially important. A single group can be followed and measured, but without a concurrent comparator the study cannot directly distinguish an intervention-associated change from changes that might occur over time for other reasons. For readers learning biostatistics, this is a clear example of why the question, design, endpoint, and analysis must be considered together rather than interpreting a measure in isolation.
The record also shows why completeness of reporting matters. A defined endpoint and planned summary do not allow readers to assess the result unless the estimate, its variability, analysis population, and methods are reported. Listing secondary outcomes without their results or analysis details likewise prevents evaluation of whether findings were consistent across measures. The registry lists seven outcome measures but no statistical analyses.
Finally, the safety figures are counts within a small pilot record, not comparative estimates. They should be read alongside the absence of detailed event descriptions and the lack of a control group. The study’s pilot purpose can motivate further investigation, but the registry information alone does not establish what a larger study would find or whether any particular design choice was used in planning it.
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 important limitation for interpreting outcomes is that the registry record does not report numerical results for the primary or secondary endpoints. It describes the CRP measurement and its summary format but gives no median, inter-quartile range, baseline value, or change estimate. Without these, the magnitude and precision of the endpoint cannot be assessed.
The single-group design provides no concurrent control comparison. The record therefore cannot support a direct estimate of how outcomes would differ under another intervention or under no intervention. Masking is listed as none, and allocation as not applicable; the record does not describe additional procedures that might reduce bias in measurement or conduct.
The registry does not report endpoint-specific sample sizes, adherence to the supplement, participant withdrawals, reasons for missing data, or methods for handling incomplete measurements. It lists 17 enrolled participants, while the safety record lists 16 at risk; the reason for this difference is not reported. It is not possible to determine from these counts how many participants contributed to CRP or other outcomes.
The statistical analysis plan, outcome analysis methods, confidence intervals, and approach to multiple outcomes are also not reported. The registry lists seven outcome measures and zero analyses. This prevents assessment of model assumptions, the precision of estimates, or how the secondary outcomes were treated. Although a planning illustration is described, its numerical outputs and the observed effect used in that illustration are not reported, and its hypothetical two-arm assumptions do not match the single-group design.
These limitations concern what can be concluded from the registry record. They do not establish that information was not collected or analysed elsewhere; those details are simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Immuno-nutrition Supplementation in Haemodialysis — NCT05700851.
- Registry record last updated 2024-12-06; status last verified 2023-01.
- Results first posted 2024-12-06.
- 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
NCT05700851 is a completed, single-group pilot study sponsored by the University of Nottingham. It enrolled 17 people with chronic kidney disease requiring chronic dialysis. The recorded start date is 2022-09-27, and the primary completion date is 2022-12-09.
Participants were advised to take one 74 g sachet of immuno-nutrition supplement daily, dissolved in 125 ml of water, with follow-up for 6 weeks. The primary outcome was CRP at 6 weeks, expressed as a median and inter-quartile range in mg/L. Secondary outcomes include skeletal muscle mass, energy intake, protein intake, and handgrip strength.
The registry record does not report endpoint results or statistical analyses. The safety entry lists 16 participants at risk, zero affected by serious adverse events, one affected by another adverse event, and zero deaths. The analysis population, missing-data methods, and detailed adverse-event descriptions are not reported in the registry record.