Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life (NCT01181076), a randomized na study. The primary outcome is Global Quality of Life Score.

2. Clinical Question

The trial’s stated hypothesis was that individualized nutrition would be associated with better global quality of life at the specified follow-up. The registry also lists possible effects on nutritional status, oral mucositis, fever, hospital stay, engraftment, acute graft versus host disease, and other quality-of-life domains. Those outcomes provide context for the broader research question, but they do not replace the primary comparison.

The posted primary outcome is a continuous score, reported as a mean and standard deviation in each group. The comparison therefore concerns average scores, not the proportion of participants who reached a particular quality-of-life threshold. No threshold for a clinically important difference is reported in the registry record, so the numerical mean difference alone does not establish whether participants would regard a difference of that size as important.

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. Its status is completed, and enrollment is 119. The listed study start is 2010-08-10, and the primary completion date is 2017-03-01. The registry lists the phase as NA. These record details identify the trial’s broad design and timing; they do not provide a full account of how participants were recruited or followed.

Participants were assigned to individualized nutrition or a control group. The control group description states that nutrition followed established routine: oral nutrition first, followed later by parenteral nutrition. It also states that naso-jejunal tubes were not inserted and enteral nutrition was not given in that group. The intervention arm is named Individualized Nutrition, but the intervention’s specific components and delivery procedures are not reported in the registry record. The allocation sequence method, concealment procedures, and any steps used to preserve the assigned treatment are also not reported in the registry record.

The primary endpoint was global quality of life three months after transplantation. The primary outcome data include 40 participants in the individualized nutrition group and 48 in the control group. Those endpoint counts do not equal the overall enrollment; the reasons for the difference and the handling of participants without endpoint data are not reported in the registry record. The registry also lists secondary outcomes with follow-up windows ranging from three months to eight months, depending on the outcome.

The brief summary says that a minimum sample of 100 patients would be included, but it does not give the original design assumptions or a sample-size justification. The registry record does not report the intended analysis population, a detailed analysis plan, interim analyses, or a protocol-based account of the planned statistical procedures. The planning illustrations based on observed effects are separate from the trial’s original design assumptions.

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: As determined

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Global Quality of Life Score, measured over 3 month after transplantation.

The primary endpoint is the global quality-of-life score from the EORTC QLQ-C30, measured three months after transplantation. The registry describes the score as ranging from 0 to 100, with higher scores meaning better outcome. The posted results report the score as a continuous measure, giving a mean and standard deviation for each group.

Quality of life is relevant to the trial’s stated aim because the research question concerns participants’ overall experience after transplantation and intensive treatment, rather than only a clinical event or nutritional measure. A global score offers a broad summary of quality of life at the specified follow-up. It does not, on its own, show which particular aspects of quality of life account for a group difference; the registry separately lists some domain-specific quality-of-life outcomes among its planned secondary topics.

In general, a continuous endpoint can preserve information about variation in scores across participants, rather than reducing the outcome to whether each person did or did not cross a chosen threshold. The reported mean describes the group average, while the standard deviation describes the spread of individual scores around that average. Neither quantity shows the full distribution of scores, and the registry does not report a threshold for interpreting a difference as clinically important.

The endpoint is defined at a particular follow-up time, so the result addresses global quality of life at three months after transplantation. It does not establish how scores changed over time or what quality of life was like at other time points. Those additional questions are not answered by the posted primary endpoint result.

7. Results Posted in the Registry

• Individualized Nutrition: mean 58.80 versus 55.40 on control; difference 3.40 (95% CI -5.48 to 12.28), standardized effect d = 0.16; z-test p = 0.453.

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.

Number of Underweight Participants

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Individualized Nutrition: 3.4% (2/59) versus 6.7% (4/60) on control; risk difference -3.3 percentage points (95% CI -11.1 to 4.5), risk ratio 0.51 (0.10–2.67); unadjusted two-proportion z-test p = 0.414.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Individualized Nutrition and the control. The interval gives the range of effects that remain compatible with the data.

Frequency of Acute Graft Versus Host Disease Grade 3-4

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Individualized Nutrition: 11.9% (7/59) versus 21.7% (13/60) on control; risk difference -9.8 percentage points (95% CI -23.1 to 3.5), risk ratio 0.55 (0.24–1.28); unadjusted two-proportion z-test p = 0.153.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Individualized Nutrition and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants With Hospital Stay

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Individualized Nutrition: 62.7% (37/59) versus 65.0% (39/60) on control; risk difference -2.3 percentage points (95% CI -19.5 to 15.0), risk ratio 0.96 (0.74–1.26); unadjusted two-proportion z-test p = 0.795.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Individualized Nutrition and the control. The interval gives the range of effects that remain compatible with the data.

The secondary results cover several distinct clinical and participant-reported outcomes, with follow-up extending from three months to eight months. Their measures are not all on the same scale: some are participant counts, while the primary endpoint is a mean quality-of-life score. The secondary comparisons therefore provide related but separate views of the trial question, rather than alternate measurements of the primary endpoint.

Across these results, the estimated differences generally have confidence intervals that include no difference. The registry also reports unadjusted p-values for the listed secondary comparisons. Taken as a group, these results do not supply a clear, precise pattern that resolves the uncertainty in the primary mean difference. They are compatible with the primary result’s overall message that the posted data leave substantial uncertainty about group differences.

Secondary findings carry less weight than the primary result for several reasons. The primary endpoint is the outcome identified as primary in the registry, while secondary endpoints serve additional questions. The record lists multiple secondary outcomes and does not report a multiplicity strategy, so isolated unadjusted tests require caution. In general, examining multiple outcomes increases the chance that some results will look notable by chance, even when there is no systematic effect.

The registry record does not report a complete statistical analysis plan, whether every planned secondary endpoint was analyzed, or how missing outcome data were handled. It therefore does not support claims that secondary outcomes confirm, explain, or contradict the primary finding. Their most appropriate role is to describe the breadth of outcomes posted, while keeping their uncertainty and multiplicity in view.

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

• Number of Underweight Participants
• Number of Episodes With Fever
• Duration Between Stem Cell Transplantation and Day of Engraftment.
• Frequency of Acute Graft Versus Host Disease Grade 3-4
• Number of Participants With Hospital Stay
• Number of Participants With Pain, as Determined by EORTC QLQ C30
• Number of Participants With Oral Mucositis Grade 3-4

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean difference represent?

The primary outcome is continuous, and the registry reports a mean for each group. The reported mean difference is 3.4 units, calculated in the direction of individualized nutrition minus control. A positive value indicates that the observed mean was higher in the individualized nutrition group; a value of zero would indicate equal observed means. This is a comparison of group averages, not a statement that every participant in one group had a higher score than every participant in the other group.

In general, a mean summarizes the center of a set of numerical observations. A standard deviation describes how dispersed those observations are around the mean. The posted standard deviations, 19.2 and 23.3, convey that individual scores varied within both groups, but they do not reveal the full distribution, whether it was symmetric, or whether unusual observations influenced the means.

How should the confidence interval be read?

The 95% confidence interval for the mean difference extends from -5.48 to 12.28. In general, a confidence interval is a range of values compatible with the data and the statistical procedure used to construct it. Its repeated-sampling interpretation is that, under the method’s assumptions, intervals constructed in the same way would cover the fixed target parameter at the stated rate over repeated studies. It is not a probability statement that the true difference lies in this particular interval.

Because the interval includes zero, the posted primary result does not exclude no difference at the conventional two-sided significance level associated with a 95% interval. The interval also includes negative and positive values, so it does not resolve which direction the underlying difference takes. Its width is relevant: the data allow a span of possible effects rather than a narrowly determined estimate.

What does the p-value add?

The unadjusted p-value is 0.453. In general, a p-value is calculated under a null model and describes the probability of obtaining a result at least as incompatible with that model as the observed result, if the model and test assumptions hold. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The confidence interval and point estimate are needed to describe the range and direction of effects compatible with the data.

The registry record does not report a detailed primary analysis method, including whether the comparison was adjusted for baseline variables or which variance assumptions were used. The result should therefore not be attributed to an unreported model. The reported comparison is presented as the primary group-level mean difference with its confidence interval and unadjusted p-value.

Why does the endpoint’s distribution matter?

In general, methods for comparing means rely on assumptions about the sampling distribution of the estimator and the calculation of its uncertainty. With continuous data, these assumptions concern features such as independence, the distribution of observations or residuals, and the adequacy of the standard error calculation. The registry record does not describe diagnostic checks or alternative analyses. The posted summary statistics do not make it possible to assess every assumption, since individual observations and distributional details are not reported.

In general, over-dispersion means that variability is greater than a model expects. For outcomes analyzed as counts or proportions, over-dispersion can make standard errors too small if the analysis assumes less variability than is present. That concept is relevant to some types of clinical outcomes, but the registry record does not report an analysis using a dispersion model for the primary continuous quality-of-life endpoint. It would therefore be inappropriate to infer that over-dispersion was tested or corrected in this trial.

What can the secondary comparisons establish?

The secondary results include counts of participants for several outcomes, while the primary endpoint is a continuous score. In general, a risk difference compares the proportions experiencing an event in two groups; it is not the same estimand as a mean difference. These outcomes can provide complementary information, but they answer distinct questions and use different scales. A result on one endpoint does not determine the result on another.

The posted secondary comparisons include unadjusted p-values and confidence intervals, but the registry’s reported-analyses lists are empty. A full statistical analysis plan, including any model choices, covariate adjustment, or rules for handling missing values, is not reported in the registry record. The secondary results should be interpreted as posted summaries rather than as evidence that a particular unreported statistical model was used.

Why does multiplicity matter?

In general, when many outcomes or comparisons are examined, the chance of obtaining at least one apparently notable result by chance can increase. Procedures such as a prespecified hierarchy or multiplicity adjustment can address some of this concern, but the registry record does not report a strategy for controlling multiple comparisons. It also does not report which secondary outcomes, if any, were designated as confirmatory. Accordingly, isolated secondary p-values warrant caution and should not be treated as if they were the sole prespecified test.

The primary endpoint is clearly identified in the record, which distinguishes it from the listed secondary outcomes. However, without a documented analysis plan, the record does not establish how the primary and secondary tests were organized, whether all planned outcomes were reported, or whether any outcome definitions changed. These gaps limit the ability to assess selective reporting or reproduce the full analysis.

11. Confidence Intervals and Precision

The primary mean difference is 3.4 units, with a 95% confidence interval from -5.48 to 12.28. This interval is the main guide to statistical precision: it shows that the data are compatible with a range of values, including differences in either direction. The point estimate alone would conceal that uncertainty. The interval does not establish that all values within it are equally plausible, and it is not a range containing a known proportion of individual participants’ scores.

In general, precision depends on factors such as the amount of information available and the variability of the outcome. The primary endpoint is reported for 40 participants in the individualized nutrition group and 48 in the control group, with standard deviations of 19.2 and 23.3. The registry does not report why these endpoint counts differ from total enrollment or provide a missing-data analysis, so the effect of incomplete endpoint information cannot be assessed from the record.

The interval crosses zero, so the data do not determine whether the average score was higher or lower under individualized nutrition in the underlying population. The upper and lower bounds also allow effects of differing magnitudes. A confidence interval is not a test of clinical importance: no interpretation threshold for an important difference is reported in the registry record.

In general, greater precision would be reflected by a narrower interval under comparable assumptions. The interval’s width does not by itself reveal why the estimate is uncertain, and it should not be used to infer the trial’s original power or planned sample size. The registry record does not report the assumptions used to design the trial or a prespecified precision target.

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 figures are planning illustrations based on fractions of the observed effect, not the trial’s original design calculation. For the continuous primary outcome, the figures are participants per arm, rather than total participants across both arms or total events. The accompanying curve is intended to show how the planning requirement changes as the effect to be detected changes; it should be read together with the stated assumptions, not as a forecast of what this trial observed.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is the stated fraction of the observed effect. The registry record does not report the original design assumptions or sample-size justification, so these illustrations cannot be taken as a reconstruction of the trial’s design.

The 80% power column describes the number of participants per arm that the planning calculation estimates would give an 80% chance of detecting the specified effect under the stated assumptions. The 90% power column gives the corresponding planning number for a 90% chance. In general, power is a design property calculated for a specified effect and assumptions; it is not a probability that a particular observed result is true.

The rows for planning at 100%, 75%, and 50% of the observed effect make the effect-size dependence explicit: smaller effects require more participants to detect them with the same target power and significance level. These numbers are not observed power. They are hypothetical planning illustrations, and they do not change the uncertainty in the posted trial estimate.

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 = 3.400; pooled standard deviation σ = 21.538.
2. n = 2 × (1.96 + 0.842)² × 21.538² / 3.400² = 629.9, rounded up to 630 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 <- 3.4                      # observed difference in means
sigma <- 21.537633369588                     # 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(1181076)
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 = 630 (80% power), 844 (90% power)
 75% of observed effect: n per arm = 1,120 (80% power), 1,500 (90% power)
 50% of observed effect: n per arm = 2,520 (80% power), 3,374 (90% power)
power.t.test: 630.9 
Simulated power at n = 630 per arm: 0.800 (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. Multiplicity, Missing Data and Analysis Populations

The registry identifies global quality-of-life score as the primary endpoint and lists secondary outcomes. However, the reported-analyses lists are empty, and the record does not describe a prespecified hierarchy of tests, a family of outcomes for multiplicity control, or an adjustment procedure. The posted p-values for the secondary comparisons are unadjusted. In general, when many outcomes are tested, interpreting each p-value as if it arose from one isolated test can overstate the strength of evidence. The absence of a reported strategy does not show that no strategy was used; it means the strategy is not reported in the registry record.

Missing data are another important uncertainty. The primary endpoint results include 40 participants in the individualized nutrition group and 48 in the control group, while total enrollment is 119. The secondary outcomes use other group counts. The registry record does not explain these differences, report the amount or reasons for missing data, or describe imputation, complete-case analysis, or sensitivity analyses. It is therefore not possible to determine from the registry how missing observations may have affected the estimates.

The analysis population is also not reported in sufficient detail. Randomized allocation is recorded, but the registry does not state whether the primary comparison followed an intention-to-treat principle, included only participants with observed scores, or used another population definition. The numbers contributing to the reported endpoint should not be assumed to identify the analysis population or the disposition of every randomized participant.

Other statistical-plan details, including covariate adjustment, handling of protocol deviations, and interim analyses, are not reported in the registry record. These omissions limit reproducibility and make it difficult to distinguish planned analyses from analyses selected after results were available. They do not alter the numerical estimates posted, but they constrain how confidently the analysis process can be evaluated.

15. 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 0% reporting threshold.

The registry lists 59 participants at risk for serious adverse events in the individualized nutrition group and 60 in the control group. It records 0 serious adverse events in each group. The other adverse-event counts are also 0 in each group. These are reported counts, not evidence that no events of any kind occurred outside the registry’s defined reporting categories or observation process.

The record also lists 9 deaths in the individualized nutrition group and 5 in the control group. These death counts should be read separately from the serious and other adverse-event counts; the registry does not state that the deaths were caused by the assigned nutrition strategy. It does not report causes of death, timing, relatedness assessments, or a comparative safety analysis.

The at-risk counts differ from the group counts reported for the primary endpoint. The registry record does not explain the relationship among these denominators or provide additional details about safety follow-up. These figures are therefore descriptive registry entries, not a basis for attributing benefit or harm to either group.

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

The primary result describes a modestly positive observed difference in mean global quality-of-life scores for the individualized nutrition group, with substantial uncertainty around the estimate. Its confidence interval includes zero and values in both directions. The result therefore does not establish a clear difference between groups, nor does it demonstrate that the groups are equivalent.

The endpoint is a global quality-of-life score measured three months after transplantation. It does not describe every aspect of participants’ health, nutritional status, or longer-term experience. The registry lists other outcomes, but these are separate comparisons with their own uncertainty and follow-up periods. The primary score also does not show whether particular individuals experienced improvement or worsening.

In general, a nonsignificant result should not be interpreted as proof of no effect. A study may be compatible with a range of effects because of uncertainty, and evidence for equivalence requires a prespecified equivalence margin and a suitable analysis. Neither is reported in the registry record. At the same time, the positive point estimate alone is not proof of a meaningful difference. The registry does not report a threshold for clinical importance.

The posted data also do not establish why any observed difference occurred. The registry record does not fully describe the individualized nutrition regimen, analysis population, missing-data handling, or adjusted analysis. Those omissions limit both causal interpretation and reproducibility. The safety figures are counts and do not establish whether any death or event was related to an assigned group.

Overall, the results are best understood as an imprecise comparison of mean global quality-of-life scores at one follow-up point, alongside secondary descriptive outcomes. They do not support a definitive conclusion about the direction, size, or clinical importance of a difference. They also do not provide medical advice or determine an appropriate nutritional approach for an individual patient.

17. Why This Trial Matters Statistically

This trial is statistically informative because its primary endpoint is a patient-reported global quality-of-life measure at a defined follow-up after transplantation. That focus complements the registry’s clinical and nutritional outcomes and makes clear that the research question was not limited to survival or a single complication. The score’s stated direction also makes the reported mean difference interpretable: higher values indicate better outcome.

The result illustrates why a point estimate and its uncertainty need to be read together. The mean difference is positive, but the confidence interval includes both negative and positive values. A single estimate cannot capture this uncertainty, and a p-value alone would not describe the range of effects compatible with the data. Considering all three—the estimate, interval, and p-value—gives a more complete account of what the posted primary result can support.

The record also illustrates the distinction between sample-size planning and observed trial evidence. The planning illustrations are based on the observed effect and explicit hypothetical assumptions; they are not the original study design and do not report observed power. This distinction matters because retrospective planning figures cannot replace a protocol-based sample-size justification.

Finally, the record’s gaps have statistical importance. The endpoint counts differ from enrollment, while missing-data procedures, analysis populations, multiplicity handling, and detailed analysis methods are not reported. Such information is needed to assess reproducibility and understand the limits of inference. A careful reading can recognize what the registry reports without treating unreported methods or clinical interpretations as established details.

18. 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 registry record gives limited detail about the intervention. It names individualized nutrition but does not report the specific regimen, how individual needs were assessed, or how the intervention was delivered. This limits the ability to interpret what exposure the intervention group received and whether the approach could be reproduced from the registry description alone. The control care is described more specifically, but the record does not report whether routine care varied across participants.

The primary endpoint counts are smaller than total enrollment, and the record does not explain the difference. It also does not report missing-data methods or the analysis population. These gaps make it difficult to assess the potential influence of unavailable outcome measurements. The registry does not provide participant characteristics that would allow readers to evaluate the composition of the analyzed groups or the applicability of the result to particular subgroups.

The statistical plan is incompletely described. The record does not report the trial’s original sample-size assumptions, covariate adjustment, interim analyses, or multiplicity handling. The reported secondary analyses are unadjusted, and the record does not establish which were intended to be confirmatory. This limits interpretation of multiple outcomes and the ability to reproduce the analysis process.

The primary result concerns a single follow-up time, three months after transplantation. The registry does not report repeated primary measurements that would show change over time or establish persistence of any difference. It also does not report a threshold for a clinically important quality-of-life difference. Consequently, the statistical estimate cannot be translated into a registry-based judgment about clinical importance.

These are limitations of the information reported in the registry record; they do not establish that the trial lacked procedures or analyses that are not described there.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life — NCT01181076.
• Registry record last updated 2020-01-22; status last verified 2020-01.
• Results first posted 2020-01-22.
• 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.

22. Record Summary

NCT01181076 is a completed randomized, parallel-group trial sponsored by Oslo University Hospital. It enrolled 119 participants and compared individualized nutrition with a control group receiving nutrition according to established routine. The registry lists no masking and identifies the primary endpoint as global quality-of-life score three months after transplantation.

The posted primary means were 58.8 (standard deviation 19.2) for 40 participants in the individualized nutrition group and 55.4 (standard deviation 23.3) for 48 control participants. The mean difference was 3.4, with a 95% confidence interval from -5.48 to 12.28 and an unadjusted p-value of 0.453. The interval includes zero and spans values in both directions.

The record lists secondary outcomes and adverse-event counts, but does not report a full statistical analysis plan, missing-data methods, analysis populations, or a multiplicity strategy. The primary result is therefore best read as an uncertain group comparison at the specified follow-up, without assuming unreported analyses or clinical importance.