Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition (NCT00998517), a randomized na study. The primary outcome is Number of Participants With Nutritional Recovery.

2. Clinical Question

The primary comparison is about the observed recovery counts and the precision of differences between groups. The unadjusted risk differences calculated from the posted counts are 0.018 for soy/peanut fortified spread versus milk fortified corn/soy blend, and 0.020 for Supplementary Plumpy® versus milk fortified corn/soy blend. Both corresponding confidence intervals include zero, so the posted summaries do not establish a clear difference in recovery between either alternative and the reference group.

The question is limited to the outcomes and follow-up specified in the registry record. It does not establish whether the foods have the same effects in other populations or settings, or whether the observed recovery pattern reflects other outcomes such as longer-term nutritional status. Those questions require evidence beyond these primary results.

3. Trial Design

This was a randomized, parallel-group clinical effectiveness trial with single masking. The official title describes the masking as investigator-blinded. The registry record identifies three dietary supplements: milk fortified corn/soy blend, soy/peanut fortified spread, and Supplementary Plumpy®. The trial enrolled 2712 participants and is listed as completed. The registry record gives a start date of 2009-10 and a primary completion date of 2011-02.

The primary outcome was the number of participants with nutritional recovery. Its timeframe was 12 weeks or upon completion of recovery. Recovery was defined as a weight-for-height Z score of -2 or greater, calculated using enrollment length and standard WHO growth standards. The posted arm counts were 763.0 of 888.0 for milk fortified corn/soy blend, 795.0 of 906.0 for soy/peanut fortified spread, and 807.0 of 918.0 for Supplementary Plumpy®.

The registry record also lists secondary outcomes covering rate of weight gain, adverse outcomes, fever, cough and diarrhea during the first two weeks of treatment, remaining well-nourished through 12 months after successful treatment, and gains in mid-upper arm circumference and length. Posted numerical results are available for rate of weight gain at 4 weeks. Detailed results for the other listed secondary outcomes are not reported in the registry record.

The record identifies Washington University School of Medicine as the sponsor. It does not report the randomization method, allocation concealment procedures, the precise masking procedures, treatment dose or duration, adherence measures, or co-interventions. The phase is listed as NA. The trial’s original sample-size justification, design assumptions, interim analyses, and full statistical analysis plan are not reported in the registry record.

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

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 Number of Participants With Nutritional Recovery, measured over 12 weeks or upon completion of recovery.

The primary endpoint counts participants who met the trial’s definition of nutritional recovery. Recovery required a weight-for-height Z score of -2 or greater, calculated using enrollment length. The endpoint timeframe was 12 weeks or upon completion of recovery. The posted results give the count meeting the definition and the group denominator for each food.

A binary recovery outcome is useful because it represents whether each participant crossed a prespecified clinical threshold, rather than describing only an average change in weight or growth. Comparing the proportion recovered in each group can therefore address whether the groups differed in the frequency of reaching that endpoint during the stated period. The registry record links the definition to standard WHO growth standards, but does not report further details of how measurements were collected or how endpoint assessments were handled.

The group counts are 763.0 of 888.0 for milk fortified corn/soy blend, 795.0 of 906.0 for soy/peanut fortified spread, and 807.0 of 918.0 for Supplementary Plumpy®. The percentages represented by the posted rates are 0.859, 0.877, and 0.879, respectively. These rates are descriptive; the comparative estimates and their confidence intervals are needed to assess the uncertainty around differences between groups.

The endpoint does not, by itself, describe the amount of weight gained, the timing of recovery, or whether recovery was maintained after the stated timeframe. Those aspects require other outcomes and follow-up information. The registry record’s primary endpoint is a count of participants meeting the recovery definition, not a continuous measure of nutritional change.

7. Results Posted in the Registry

• Soy/Peanut Fortified Spread: 87.7% (795/906) versus 85.9% (763/888) on control; risk difference 1.8 percentage points (95% CI -1.3 to 5.0), risk ratio 1.02 (0.99–1.06); unadjusted two-proportion z-test p = 0.253.
• Supplementary Plumpy®: 87.9% (807/918) versus 85.9% (763/888) on control; risk difference 2.0 percentage points (95% CI -1.1 to 5.1), risk ratio 1.02 (0.99–1.06); unadjusted two-proportion z-test p = 0.211.

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.

Rate of Weight Gain

• 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:
  • Soy/Peanut Fortified Spread: mean 3.40 versus 3.10 on control; difference 0.30 (95% CI 0.07 to 0.53), standardized effect d = 0.12; z-test p = 0.011.
  • Supplementary Plumpy®: mean 3.60 versus 3.10 on control; difference 0.50 (95% CI 0.26 to 0.74), standardized effect d = 0.19; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Soy/Peanut Fortified Spread than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Supplementary Plumpy® than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary-outcome record is uneven. Numerical group summaries and unadjusted comparisons are posted for rate of weight gain at 4 weeks. The registry also lists outcomes involving adverse outcomes, fever, cough and diarrhea during the first two weeks of treatment, remaining well-nourished through 12 months after successful treatment, and gains in mid-upper arm circumference and length. Numerical findings for those other listed outcomes are not reported in the registry record.

The weight-gain outcome measures a continuous average, whereas the primary recovery endpoint measures the number of participants who met a threshold. These outcomes can complement one another: a difference in average gain need not translate directly into a difference in the proportion crossing the recovery threshold, and a threshold-based outcome does not describe the full distribution of individual growth. The secondary summaries therefore add a distinct view of the measured outcomes but do not replace the primary endpoint.

The weight-gain comparisons are unadjusted re-calculations from posted means and standard deviations, and the registry record lists no reported analyses for the secondary outcomes. They should be treated as exploratory descriptions rather than as a complete confirmatory analysis. The record does not state a hierarchy of secondary hypotheses, a multiplicity adjustment, or a prespecified plan for interpreting them alongside the primary result.

When many outcomes or comparisons are considered, the chance of at least one apparently unusual result can increase. This general multiplicity concern means that isolated unadjusted secondary findings carry less weight than a result supported by a prespecified analysis and interpreted in the context of the full outcome set. Missing numerical results for several listed outcomes also make it impossible to assess the overall pattern across all secondary measures. The secondary evidence therefore provides limited additional context for the primary recovery comparisons.

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

• Rate of Weight Gain
• Number of Patients With Adverse Outcomes
• Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment
• Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)
• Rates of Gain in Mid-upper Arm Circumference, and Length

9. Statistical Interpretation

10. Statistical Methods Explained

For a binary endpoint, each participant either meets the outcome definition or does not. The registry record reports the number meeting the nutritional recovery definition and the number in each arm. The posted rates are 0.859 for milk fortified corn/soy blend, 0.877 for soy/peanut fortified spread, and 0.879 for Supplementary Plumpy®. These are descriptive arm-level rates. A comparative estimate expresses how far one group’s outcome rate is from the reference group’s rate.

What does a risk difference express?

A risk difference subtracts the reference group’s rate from the other group’s rate. A positive estimate means the outcome rate was higher in the named group in the posted summaries; a negative estimate would mean it was lower. The risk differences are 0.018 for soy/peanut fortified spread versus milk fortified corn/soy blend, and 0.020 for Supplementary Plumpy® versus milk fortified corn/soy blend. These estimates are unadjusted calculations from the posted group counts and denominators.

The risk difference is an absolute comparison on the outcome-rate scale. It answers how much the observed recovery rate differs between the two groups, rather than expressing the difference as a relative multiplier. The posted results also include relative measures, but the absolute risk difference is sufficient to interpret the main comparison when read alongside its confidence interval. Neither measure alone establishes a causal explanation for the observed pattern; interpretation depends on the trial design and the quality and completeness of outcome data.

How should the confidence interval be read?

A confidence interval describes the uncertainty around an estimate under the assumptions of the method used. A narrower interval indicates greater precision, while a wider interval leaves a broader range of plausible values. For the soy/peanut fortified spread comparison, the 95% confidence interval for the risk difference is -0.013 to 0.050. For Supplementary Plumpy®, it is -0.011 to 0.051. Both intervals include zero, the value corresponding to no difference on the risk-difference scale. Their inclusion of zero means the posted estimates are not precise enough to establish a difference from the reference group in these unadjusted comparisons.

A confidence interval is not a guarantee that the true effect lies within its limits, and it does not give the probability that one particular effect is true. It is an interval generated by a statistical procedure that, under repeated use and its assumptions, has the stated coverage property. The registry record does not describe all analysis assumptions or provide sponsor-run inferential analyses for the primary endpoint.

What does an unadjusted p value contribute?

The unadjusted p values are 0.253 for soy/peanut fortified spread and 0.211 for Supplementary Plumpy®. A p value measures how unusual data at least as discordant with a specified null hypothesis would be if that hypothesis and the statistical model were correct. It is not the probability that the null hypothesis is true, nor does it measure the clinical importance of a difference. The values should be considered together with the estimates and confidence intervals, not used as a stand-alone verdict.

These are unadjusted results. The registry record does not report whether a multiplicity procedure was planned or applied. When several hypotheses are tested, unadjusted p values do not account for the increased opportunity to obtain a small value across the family of tests. This matters particularly when interpreting secondary outcomes and multiple treatment comparisons. It does not change the numerical values; it affects how much confirmatory weight to place on them.

Why can variation affect estimates?

For continuous outcomes, such as rate of weight gain, the analysis compares group means and takes account of variation among participants. Greater variation generally makes an estimated mean difference less precise when other features are held constant. Over-dispersion is a general statistical concern for count or binary data when observed variability exceeds what a simple model assumes; if present and ignored, standard errors and confidence intervals may be too optimistic. The registry record does not report a model-based analysis of the primary binary endpoint, so this general point should not be mistaken for a claim that over-dispersion occurred in this trial.

The posted weight-gain comparisons use mean differences and standard deviations. Their interpretation differs from the binary recovery comparison: a mean difference concerns the average rate of gain, while recovery counts whether each participant crossed a threshold. The registry record supplies no reported analyses for those secondary comparisons, so the posted contrasts are descriptive, unadjusted calculations rather than evidence of a prespecified inferential plan.

What analysis details remain unknown?

The registry record does not report the randomization procedure, allocation concealment, the intended analysis population, handling of missing outcomes, model specification, covariate adjustment, or the original sample-size justification. It also does not report interim analyses or a complete statistical analysis plan. These omissions prevent a full appraisal of whether the displayed comparisons match the trial’s intended primary analysis. The observed counts and unadjusted calculations remain interpretable as posted summaries, but their inferential status should not be overstated.

11. Confidence Intervals and Precision

Precision concerns how tightly the data estimate a group difference. For the primary recovery outcome, the risk difference for soy/peanut fortified spread versus milk fortified corn/soy blend is 0.018, with a 95% confidence interval from -0.013 to 0.050. The risk difference for Supplementary Plumpy® versus milk fortified corn/soy blend is 0.020, with a 95% confidence interval from -0.011 to 0.051.

Each interval crosses zero, so both are compatible with no difference on the risk-difference scale. They also extend to positive values, meaning the posted summaries do not exclude a higher recovery rate in either compared group. Their negative limits leave open a lower rate as well. The intervals therefore express uncertainty in both direction and magnitude, rather than showing that the true difference is zero.

The observed arm rates are 0.859 for milk fortified corn/soy blend, 0.877 for soy/peanut fortified spread, and 0.879 for Supplementary Plumpy®. The point estimates favor the two comparison groups numerically, but point estimates are only single values within a broader uncertainty range. The confidence intervals are more informative about how much uncertainty accompanies those estimates.

Precision is not the same as clinical importance. Whether a range of possible differences matters depends on clinical context and any prespecified threshold for a meaningful effect. Such a threshold is not reported in the registry record. The record also does not report a non-inferiority or equivalence margin, so the confidence intervals cannot be used to claim that the foods are equivalent. A result that is not statistically distinguishable from zero is not proof of no effect; it is a statement about the information and uncertainty in these 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 planning figures are participants per arm for these non-time-to-event outcomes, not total events. They are illustrations based on the observed effect, rather than the trial’s original design justification. The registry record’s planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The planning exercise considers the stated share of the observed effect as the effect to detect. The trial’s own original design assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design that would have an 80% chance of detecting the specified effect under the planning assumptions, if that effect were the true one and the analysis assumptions held. The 90% power column gives the corresponding per-arm planning number for a 90% chance. These are design-planning quantities, not estimates of how likely the completed trial was to find a result after observing its data.

Rows that plan for 75% or 50% of the observed effect use smaller target effects than the row based on 100% of the observed effect. Smaller effects are harder to distinguish from random variation, so they require more participants per arm to reach the same target power under otherwise unchanged assumptions. This pattern is a general feature of sample-size planning, not evidence that the smaller effects occurred in the trial.

The figures are not observed power. Observed power is not a useful substitute for reading the actual effect estimate and its confidence interval: after a study is complete, the interval directly communicates the uncertainty in the estimated effect. The planning values are hypothetical illustrations and should not be interpreted as enrollment recommendations without a specific future study question, target effect, population, and analysis plan.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.859; treatment proportion p₁ = 0.877; average p̄ = 0.868.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.4781 = 0.9371.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4780 = 0.4023.
4. n = (0.9371 + 0.4023)² / (0.0182)² = 5,387.0, rounded up to 5,387 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
p0 <- 0.859234234234234                          # control proportion
p1 <- 0.877483443708609                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(998517)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 5,387 (80% power), 7,212 (90% power)
 75% of observed effect: n per arm = 9,719 (80% power), 13,010 (90% power)
 50% of observed effect: n per arm = 22,182 (80% power), 29,694 (90% power)
power.prop.test: 5387 
Simulated power at n = 5,387 per arm: 0.798 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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 record lists multiple outcomes and comparisons, but does not report a statistical plan describing how multiplicity was handled. The primary endpoint compares each alternative food with milk fortified corn/soy blend, while the record also identifies several secondary outcomes. No adjustment procedure, testing hierarchy, or rule for identifying confirmatory results is reported. Consequently, the posted unadjusted p values should not be interpreted as accounting for the total set of tests that may have been considered.

Multiplicity is a general statistical issue: when many hypotheses are tested, the chance of at least one result appearing unusual by chance can rise. Adjustments or a prespecified hierarchy can help control that issue, but the registry record does not indicate whether either approach was used. This uncertainty is especially relevant to secondary outcomes and should temper claims based on individual unadjusted findings. It does not establish that the reported estimates are wrong; it limits what can be concluded about their confirmatory status.

Missing-data methods are not reported in the registry record. The record does not state whether every randomized participant had a primary outcome measurement, how missing endpoint status was handled, whether any imputation was used, or whether sensitivity analyses were conducted. The posted denominators are 888.0, 906.0, and 918.0 for the three arms, but the record does not specify the analysis population convention behind those denominators. They should not automatically be interpreted as evidence that every randomized participant was included under a particular intention-to-treat or per-protocol definition.

The registry record also does not report whether outcome assessors were blinded in practice beyond the trial’s single-masking designation, how endpoint disagreements were resolved, or how participants who did not recover by the stated timeframe were treated analytically. The official title calls the trial investigator-blinded, but operational details are not reported. These gaps matter because outcome handling and analysis population can influence the estimated effect and its uncertainty.

Without these details, the displayed re-calculations provide a transparent account of the posted counts but cannot substitute for a full statistical analysis report. A complete assessment would need the prespecified analysis plan, participant flow, missingness information, and any sponsor-run models or sensitivity analyses; those are not reported in the registry record.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry record lists serious and other adverse events by group. For milk fortified corn/soy blend, 0 of 888 participants were recorded as affected for serious events and 0 of 888 for other events. For soy/peanut fortified spread, the corresponding counts are 0 of 906 and 0 of 906. For Supplementary Plumpy®, they are 0 of 918 and 0 of 918. These are the event counts posted in the registry record.

Zero recorded affected participants does not establish that no adverse events occurred in the trial or that the foods had no safety risks. It describes what was entered in these registry fields. The record does not report detailed event definitions, ascertainment procedures, event timing, severity criteria, or a narrative of events. Death counts are not reported in the registry record. The listed secondary outcomes include adverse outcomes and symptoms during the first two weeks, but detailed numerical results for those outcomes are not posted.

Safety counts should be interpreted with the same attention to follow-up and completeness as efficacy outcomes. The registry record does not describe whether event monitoring covered all participants for the same duration or how missing safety information was handled. The counts are therefore a limited summary, not a comprehensive safety assessment.

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

The posted primary results show high recovery rates in all three groups under the registry’s definition and timeframe. Recovery was recorded for 763.0 of 888.0 participants receiving milk fortified corn/soy blend, 795.0 of 906.0 receiving soy/peanut fortified spread, and 807.0 of 918.0 receiving Supplementary Plumpy®. The unadjusted risk differences against the reference group are positive, but both confidence intervals include zero and allow for differences in either direction.

These results do not establish that one food produced a higher recovery rate than the reference group. They also do not establish that the foods are equivalent or interchangeable. Equivalence and non-inferiority conclusions require a suitable design, prespecified margins, and analyses aligned with those goals; such information is not reported in the registry record. A non-significant unadjusted comparison is not proof that there is no difference.

The endpoint captures whether a participant met a specified weight-for-height threshold using enrollment length by 12 weeks or upon completion of recovery. It does not fully describe individual trajectories, the amount of weight gained, later nutritional status, or every dimension of health. The registry record lists relevant secondary outcomes, but detailed results are posted only for rate of weight gain at 4 weeks. Results for several other listed outcomes are not reported in the registry record.

Generalizability is also uncertain from the registry information alone. The trial concerns rural Malawian children with moderate acute malnutrition, but detailed participant characteristics, site information, and eligibility criteria are not reported. The findings should therefore be read as evidence about the enrolled trial population and the recorded endpoint, not automatically extended to other populations, settings, or treatment circumstances.

Finally, the registry record does not report key elements needed for a complete appraisal of the analysis, including missing-data handling, analysis populations, multiplicity procedures, and the original sample-size rationale. The posted estimates are informative descriptive comparisons, but these reporting gaps limit the strength of broader conclusions that can be drawn from them.

17. Why This Trial Matters Statistically

This trial offers a useful example of why a difference in observed rates should be read together with its uncertainty. The recovery rates are numerically higher in the two comparison groups than in the milk fortified corn/soy blend group, but the risk-difference confidence intervals include zero. A point estimate alone can suggest a direction; the interval shows that the data do not precisely determine whether the underlying difference is positive, negative, or negligible.

The distinction between an outcome threshold and a continuous measure is also important. Nutritional recovery is a binary endpoint based on crossing a defined weight-for-height threshold. Rate of weight gain is a continuous outcome. Each captures a different aspect of change, and one cannot be substituted for the other. The registry record makes that distinction visible by reporting the primary recovery counts and a secondary weight-gain measure.

Planning illustrations can help readers understand how the target effect influences the number of participants needed in a future design. They are not a retrospective measure of the completed trial’s success and do not replace confidence intervals. The original sample-size justification is not reported in the registry record, so the planning figures should be understood as illustrations rather than evidence about the trial’s design choices.

The record also demonstrates how much interpretation depends on the completeness of statistical reporting. No sponsor-run analyses are listed, and details on missing data, analysis populations, multiplicity, and the original statistical plan are not reported. Clear estimates can still be read from the posted summaries, but their relationship to a prespecified analysis cannot be fully assessed. For biostatisticians and clinical researchers, separating the descriptive evidence from unreported design and analysis details is essential to a measured interpretation.

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.

Several trial-specific limitations arise from the available registry information. Although the trial is described as randomized and investigator-blinded, the randomization procedure, allocation concealment, and practical masking procedures are not reported. The official title identifies rural Malawian children with moderate acute malnutrition as the setting and population, but detailed eligibility criteria and participant characteristics are not reported. This restricts assessment of how representative the enrolled participants were.

The primary result is reported as counts and denominators, with unadjusted re-calculations from those summaries. Sponsor-run analyses are not listed in the registry record. The record does not report a prespecified analysis plan, covariate adjustment, analysis-population definitions, missing-data methods, or sensitivity analyses. It is therefore not possible to determine from the registry record whether the posted summaries correspond to the intended primary analysis or how robust the results are to alternative assumptions.

Several listed secondary outcomes lack posted numerical results. This prevents a full assessment of the wider outcome pattern, including outcomes related to adverse events, symptoms, longer-term nutritional status, mid-upper arm circumference, and length. Safety information is especially limited: the registry fields list zero affected participants for serious and other events in each group, but event definitions, monitoring details, and death counts are not reported.

The record does not report the original sample-size justification, interim analyses, or criteria for multiplicity control. It also does not report treatment dose, adherence, or co-interventions. These absences do not demonstrate flaws in trial conduct, but they limit how completely the results can be evaluated and reproduced from the registry record alone.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition — NCT00998517.
• Registry record last updated 2014-05-12; status last verified 2014-04.
• Results first posted 2014-05-12.
• 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

NCT00998517 is a completed, randomized, parallel-group, single-masked clinical effectiveness trial comparing milk fortified corn/soy blend, soy/peanut fortified spread, and Supplementary Plumpy® for moderate acute malnutrition in rural Malawian children. The registry record lists 2712 enrolled participants and names Washington University School of Medicine as sponsor. The start date is 2009-10, and primary completion is recorded as 2011-02.

The primary endpoint was the number of participants with nutritional recovery by 12 weeks or upon completion of recovery. Recovery was defined as a weight-for-height Z score of -2 or greater using enrollment length. The posted recovery counts are 763.0 of 888.0, 795.0 of 906.0, and 807.0 of 918.0, respectively. Unadjusted risk-difference confidence intervals for the comparisons with milk fortified corn/soy blend include zero.

The registry lists several secondary outcomes and posts numerical results for rate of weight gain at 4 weeks. Detailed numerical results for the other listed secondary outcomes, the original sample-size justification, and important analysis details are not reported in the registry record.