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 Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids (NCT01027143), a randomized phase 2, phase 3 study. The primary outcome is Asthma Control Questionnaire (Juniper).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01027143 |
| Phase | Phase 2, Phase 3 |
| Condition | Asthma, Obesity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 143 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Nemours Children's Clinic |
| Results posted | Yes |
2. Clinical Question
Population
People with asthma and obesity. The registry record does not report further eligibility details or the ages of participants. Its description of the ACQ notes a poor-control threshold for children, but that does not establish the ages enrolled in this trial.
Intervention
Omega-3 fatty acids, described as three softgels containing EPA and DHA twice daily. The registry also lists omega-3 polyunsaturated fatty acids as a dietary supplement and Omega-3 Fatty Acid as a drug.
Comparator
Soybean oil, described as three matched softgel capsules twice daily.
Primary question
How did the mean Asthma Control Questionnaire score change across baseline, 3 months, and 6 months in the omega-3 and control groups, and did genetic variation influence response? Numerical primary-outcome results and a reported genetic-response analysis are not reported in the registry record.
The trial’s stated purpose was to assess whether omega-3 supplementation could help control asthma symptoms among people with obesity and asthma, and whether genes influence response. The registry identifies asthma control as the primary outcome, measured with the Asthma Control Questionnaire (Juniper). Its scale ranges from 0 to 6, with higher scores indicating worse asthma control. The record describes the outcome as a mean score with a 95% confidence interval at baseline, 3 months, and 6 months.
This question has two parts: a comparison between the supplement and control groups, and an inquiry into whether response varies by genetic characteristics. The record describes the latter as an aim, but does not report a specific genetic analysis or result. The registered outcome information also does not provide group means, confidence intervals, or a contrast between groups at any time point. Accordingly, the registry description establishes what was intended to be measured, but does not establish the direction or size of an observed treatment difference.
3. Trial Design
The registry lists this study as randomized, quadruple-masked, and parallel-group, with phases 2 and 3. It names Nemours Children's Clinic as the sponsor and reports enrollment of 143. The trial is marked completed. Its recorded start is 2010-07, and primary completion is listed as 2016-10-22. These dates describe the registry record and do not, by themselves, explain the timing of recruitment or analysis.
Participants were assigned to an omega-3 fatty-acid group or a control group receiving soybean oil. The omega-3 arm description specifies three EPA and DHA softgels twice daily; the control description specifies three matched soybean-oil softgel capsules twice daily. The record identifies the assignment as randomized and masking as quadruple, but does not identify which roles were masked or describe the randomization procedure, allocation concealment, or how adherence was assessed. Those details are not reported in the registry record.
In general, a parallel-group design assigns participants to a group and follows the assigned groups over the study period. Randomization can reduce systematic differences between groups at assignment, although it cannot ensure that every characteristic is balanced. Masking can reduce the influence of knowledge about assignment on care, reporting, or assessment; the practical effect depends on who is masked and whether masking is maintained. The registry classification alone does not establish those implementation details.
The primary outcome was assessed at baseline, 3 months, and 6 months. The record also lists secondary outcomes involving granulocyte and monocyte n3-to-n6 PUFA ratios, the Asthma Control Test, urinary leukotriene-E4, FEV1, exacerbations, and phone contacts. It lists 8 outcome measures. A numerical primary-outcome result, the analysis population, and the statistical 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.
Before assignment: 30 were excluded due to medical history and 15 was lost to follow-up during run-in.
Overall Study
| Stage | Omega-3 Fatty Acids | Control |
|---|---|---|
| STARTED | 77 | 21 |
| COMPLETED | 68 | 17 |
| NOT COMPLETED | 9 | 4 |
Reasons for not completing this period:
| Reason | Omega-3 Fatty Acids | Control |
|---|---|---|
| Lost to Follow-up | 9 | 4 |
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 | Omega-3 Fatty Acids | Control | Total |
|---|---|---|---|---|
| Participants analysed | 77 | 21 | 98 | |
| Age, Continuous | years | 14.6 (SD 2.2) | 14.6 (SD 2.2) | 14.6 (SD 2.1) |
| Sex: Female, Male: Female | Participants | 40 | 11 | 51 |
| Sex: Female, Male: Male | Participants | 37 | 10 | 47 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 20 | 7 | 27 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 57 | 14 | 71 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 40 | 10 | 50 |
| Race (NIH/OMB): White | Participants | 30 | 9 | 39 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 5 | 2 | 7 |
| Region of Enrollment: United States | participants | 77 | 21 | 98 |
6. Primary Endpoint
The registry lists the primary outcome as Asthma Control Questionnaire (Juniper), measured over baseline, 3 months, 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Asthma Control Questionnaire (Juniper), reported as a mean score on a scale at baseline, 3 months, and 6 months. The ACQ ranges from 0 to 6, and higher values indicate worse asthma control. The registry describes a score greater than 1.25 in children as poor asthma control, and a change of 0.4 or greater as clinically meaningful. These are interpretive thresholds recorded for the measure; they are not trial results.
A symptom questionnaire can capture aspects of asthma control that are not represented by a physiological measurement alone. A mean score gives a group-level description, while the spread of individual scores and uncertainty around the mean affect how precisely that description represents the group. The stated 95% confidence interval is intended to communicate uncertainty around the mean at each assessment. The registry record does not report the actual means or confidence intervals, so it is not possible to assess the observed level of asthma control or its change over time from the registered outcome description.
The three assessment times matter to interpretation: a baseline value describes the starting measurement, while later measurements describe the outcome at follow-up. A treatment comparison may depend on whether the analysis compares follow-up means, changes from baseline, or another model-based contrast. The specific primary comparison and method are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial question, intervention groups, primary measure, and planned assessment times, but it does not report numerical results for the primary ACQ outcome. In particular, the record contains no group means, confidence intervals, or stated between-group estimate at baseline, 3 months, or 6 months. The direction and size of any observed difference, and its precision, are therefore not reported in the registry record. A conclusion about whether asthma-control scores differed cannot be drawn from the outcome description alone.
The record identifies the ACQ as a mean continuous measure. For interpretation, a mean describes the group average rather than the experience of every participant. A confidence interval communicates uncertainty in the estimated mean or contrast under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but precision does not by itself establish clinical importance. Here, the record names 95% confidence intervals as the dispersion measure but does not report the numerical intervals.
The ACQ information supplies context for judging a reported result: higher values reflect worse control, and the record states that a change of 0.4 or greater is considered clinically meaningful. The score threshold greater than 1.25 is described for children. That threshold should not be applied as a characterization of this trial population, because participant ages are not reported in the registry record. Nor can the meaningful-change criterion be compared with a trial estimate when the estimate is absent.
The study also aimed to assess whether genes influence response. That aim raises a question about whether the treatment contrast differs across genetic characteristics, rather than only whether average outcomes differ between randomized groups. Such an assessment generally requires a defined genetic measure and a clearly specified comparison. Neither a reported genetic analysis nor its numerical result is reported in the registry record.
Safety information is reported separately from the primary endpoint. The registry lists serious adverse events and other adverse events by group, as well as deaths. These counts describe recorded safety data, not the ACQ treatment effect. They should not be used to infer the primary outcome, and they do not resolve the absence of numerical asthma-control results. Overall, the registry record supports a description of the trial’s design and intended outcome measurement, but does not support an estimate of the primary treatment effect.
9. Statistical Methods Explained
The registry classifies the primary outcome as continuous and reports it as a mean. A continuous outcome can take values across a scale rather than representing only a category. In general, the mean is calculated from the observed values and summarizes their central level. It can be useful for comparing groups, but it does not show how widely individual observations vary or whether a small number of values strongly influence the average. The ACQ scale runs from 0 to 6, and higher values indicate worse asthma control.
What does a confidence interval communicate?
The registry names a 95% confidence interval as the measure of dispersion for the primary outcome. In general, a confidence interval describes the uncertainty associated with an estimate under the statistical method used. For a group mean, it indicates a range of values compatible with the data and method; for a between-group contrast, it would convey uncertainty around that contrast. The exact interpretation depends on the estimate and analysis. The confidence level does not mean that a particular interval has a 95% probability of containing the true value. No numerical confidence intervals or analysis method are reported in the registry record, so their width and implications cannot be assessed.
Why does the comparison need to be specified?
The outcome is scheduled at baseline, 3 months, and 6 months. There are several possible ways to compare randomized groups over repeated assessments, including comparisons of follow-up values, changes from baseline, or a model using all assessments. These approaches can answer related but nonidentical questions and can make different assumptions. This is general statistical context, not a description of the method used in the trial. The specific contrast, model, covariate adjustment, and handling of repeated observations are not reported in the registry record.
Randomization provides a basis for comparing assigned groups, because assignment is intended to make group membership independent of participant characteristics. In general, randomization does not guarantee identical groups, especially in a finite study. Adjustment for baseline measures can sometimes improve precision or account for chance imbalance, but whether such adjustment was planned or used is not reported in the registry record. The registry’s randomized classification does not identify the sequence-generation procedure or how assignment was concealed.
What do the planning illustrations represent?
The sample-size assumptions described for the planning illustrations use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The illustrations are based on the observed effect, with the effect to detect set as a stated fraction of that observed effect. For outcomes other than time-to-event outcomes, the quantity is participants per arm; time-to-event planning uses a total event count. These are planning assumptions, not a description of the trial’s original design calculation. The registry record does not report the trial’s sample-size justification. A planning illustration is not observed power and does not provide evidence that the trial was adequately powered. Numerical illustration values are not reported in the registry record.
In general, a significance level is a decision threshold used in a testing procedure, while power is the probability of detecting an effect of a specified size under a set of assumptions. Neither quantity is a measure of the observed effect or its clinical importance. A sample-size calculation depends on the effect size, variability, allocation, and analysis assumptions. When an illustration uses an observed effect as its starting point, the resulting sample-size figures are conditional on that effect and the stated assumptions; they should not be treated as the trial’s prospectively chosen target or as proof of the result’s reliability.
Why can over-dispersion matter?
For general statistical context, over-dispersion occurs when data vary more than an analysis model expects. If a model understates that variability, standard errors can be too small and confidence intervals too narrow, making evidence appear more precise than it is. Appropriate methods may account for extra variation, depending on the outcome and model. The registry describes the primary outcome as a continuous mean and does not report a model, a variance assumption, or an over-dispersion assessment. This concept should therefore not be read as a finding about this trial.
The record describes a randomized, quadruple-masked, parallel study, but those design labels do not specify the analysis. It lists one analysis and eight outcome measures, while also noting that the primary outcome has several categories or time points and is not reduced to one comparison. The analysis population, estimand, missing-data method, multiplicity procedure, and interim-analysis plan are not reported in the registry record. These omissions limit the extent to which the registered outcome description can be used to reconstruct the statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The primary ACQ outcome is listed at baseline, 3 months, and 6 months. Assessing an outcome at several times creates more than one possible summary or contrast. In general, when several hypotheses are tested, the chance of obtaining at least one apparently notable result can increase unless the analysis plan addresses multiplicity. Methods for addressing this include specifying a primary time point, defining a primary contrast in advance, or adjusting inference across comparisons. The registry record does not report a multiplicity procedure or identify a single time-point comparison. It notes that the primary outcome has several categories or time points and is not reduced to one comparison.
Missing observations can also affect interpretation. In general, the consequences depend on how much information is missing, why it is missing, and how the analysis handles it. A complete-case analysis, imputation method, or model using available repeated measurements can rely on different assumptions. The registry record does not report the amount or pattern of missing primary-outcome data, the missing-data method, or sensitivity analyses. It is therefore not possible to assess whether missingness may have affected the estimated result.
The registry does not identify the analysis population, such as whether the primary analysis included participants according to randomized assignment or only those with available outcome measurements. Enrollment is reported as 143, but this number alone does not identify who contributed to each outcome analysis. The registered information also does not describe exclusions after randomization, adherence requirements, or handling of protocol deviations. These analysis-population details are not reported in the registry record, limiting assessment of how the randomized design was carried through to the outcome analysis.
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 |
|---|---|---|---|
| Omega-3 Fatty Acids | 3 | 77 | 3.9% |
| Control | 0 | 21 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Omega-3 Fatty Acids | 0 of 77 |
| Control | 0 of 21 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Omega-3 Fatty Acids | 58 of 77 |
| Control | 15 of 21 |
Most frequent serious adverse event terms
| Event term | Organ system | Omega-3 Fatty Acids | Control |
|---|---|---|---|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | 2 of 77 | 0 of 21 |
| vomiting | Gastrointestinal disorders | 1 of 77 | 0 of 21 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Omega-3 Fatty Acids | Control |
|---|---|---|---|
| Headaches | Nervous system disorders | 39 of 77 | 8 of 21 |
| URI | Respiratory, thoracic and mediastinal disorders | 31 of 77 | 8 of 21 |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | 20 of 77 | 8 of 21 |
| Nausea | Gastrointestinal disorders | 21 of 77 | 4 of 21 |
| Dry Mouth | Immune system disorders | 14 of 77 | 5 of 21 |
| Flatulence | Gastrointestinal disorders | 14 of 77 | 5 of 21 |
| Rash | Skin and subcutaneous tissue disorders | 15 of 77 | 2 of 21 |
| Diarrhea | Gastrointestinal disorders | 11 of 77 | 5 of 21 |
| Bloating | Gastrointestinal disorders | 11 of 77 | 2 of 21 |
| Constipation | Gastrointestinal disorders | 8 of 77 | 2 of 21 |
Serious events with the highest arm-level rate: asthma exacerbation (2.6%), vomiting (1.3%).
The registry lists serious adverse events by group. For omega-3 fatty acids, it reports 3 affected among 77 at risk; for control, it reports 0 affected among 21 at risk. It lists 0 deaths in each group. The top serious adverse-event terms are asthma exacerbation at 2.6% and vomiting at 1.3%. These entries should be read as the safety information recorded in the registry, not as a complete description of every event or of its relationship to treatment.
Other adverse events are listed separately: 58 affected among 77 at risk in the omega-3 group, and 15 affected among 21 at risk in the control group. The registry reports these counts but does not provide details in the available record about event severity beyond the serious-event classification, timing, recurrence, or attribution. The denominators listed for safety should not be assumed to represent the analysis population for the primary ACQ outcome.
In general, adverse-event counts describe events recorded under a study’s reporting procedures. Differences in counts alone do not establish that an intervention caused or prevented an event; interpretation depends on definitions, follow-up, ascertainment, and the broader safety analysis. The registry record does not report those details or a formal comparison of safety outcomes. The figures should therefore be treated as descriptive registry entries rather than a causal estimate.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of omega-3 fatty acids with soybean oil among people with asthma and obesity, with the Asthma Control Questionnaire as the primary outcome. It specifies the scale, its direction, the assessment times, and the use of a 95% confidence interval. It also records the trial’s stated interest in whether genetic characteristics influence response. These details define the questions the study was intended to address.
They do not establish the answers. Numerical primary-outcome means, confidence intervals, and between-group estimates are not reported in the registry record. The direction, magnitude, and precision of any difference in asthma-control scores therefore cannot be determined from the record. The genetic-response analysis and its result are also not reported. The stated ACQ threshold and meaningful-change criterion provide context for interpreting estimates, but cannot substitute for those missing estimates.
The safety record lists serious and other adverse-event counts and deaths by group. These are descriptive entries. Without further details about event ascertainment, follow-up, attribution, and analysis, the counts do not establish a causal safety comparison. Nor do they answer the primary question about asthma-control scores.
General statistical interpretation requires distinguishing a treatment estimate from its uncertainty and from its clinical relevance. A precise estimate may still be too small to matter clinically; an imprecise estimate may be compatible with a range of effects. A confidence interval and a pre-specified clinical threshold can help frame that assessment when reported. In this case, no numerical primary-outcome estimate or interval is reported in the registry record, so neither precision nor clinical relevance can be evaluated.
The most defensible conclusion is limited: the registry documents the design and intended measurements, but does not report enough primary-outcome results to characterize the observed treatment effect. The study’s aims should not be mistaken for findings, and its completed status does not itself indicate what the results were.
13. Why This Trial Matters Statistically
This trial is statistically notable for combining a randomized treatment comparison with an interest in genetic variation in response. Those are distinct analytic questions. The randomized comparison concerns average outcomes between assigned groups; a genetic-response question concerns whether that comparison varies according to genetic characteristics. In general, the latter requires a clearly defined genetic measure and an explicit assessment of treatment-effect variation. The registry record states the aim but does not report the genetic analysis or result.
The primary outcome is measured repeatedly, at baseline, 3 months, and 6 months. Repeated measurements can describe change over time, but they also require a clear definition of the main contrast and a strategy for handling within-participant correlation, missing observations, and multiple comparisons. The registry record does not report these analysis details. Its note that the outcome has multiple time points and is not reduced to one comparison is important: without a specified contrast, a reader cannot identify which numerical result would answer the primary question.
The record also illustrates why a registered endpoint is not equivalent to a reported finding. It identifies the ACQ scale and interpretive thresholds, yet numerical group means and confidence intervals are not reported in the registry record. Without the estimate and its uncertainty, the statistical evidence and clinical meaning cannot be assessed. A completed trial designation does not supply that missing information.
Finally, the safety counts require their own careful interpretation. Serious and other adverse events are reported with different group denominators, but the registry does not describe the broader ascertainment or comparative analysis. This reinforces the need to separate descriptive counts from estimates of treatment effect. The main statistical lesson is to distinguish the research question, the planned measurement, the analysis, and the numerical result; the record documents the first two more fully than the latter two.
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 principal limitation for interpretation is that numerical results for the primary ACQ outcome are not reported in the registry record. No group means, confidence intervals, or between-group estimates are available in the registered information. Consequently, the size and precision of the primary treatment comparison cannot be assessed. The record’s description of the scale and thresholds does not resolve that limitation.
The outcome is listed at baseline, 3 months, and 6 months, but the specific primary contrast is not reported. It is unclear from the registry record whether the intended inference focused on a particular follow-up time, change from baseline, or a repeated-measures analysis. The record notes that the outcome has several time points and is not reduced to one comparison. A multiplicity strategy is not reported.
Details needed to assess the analysis are also absent: the analysis population, handling of missing outcomes, model specification, covariate adjustment, and sensitivity analyses are not reported in the registry record. The randomization procedure, allocation concealment, adherence assessment, and the roles covered by quadruple masking are not described. These are limitations of the available registry information and should not be taken as evidence that the trial did or did not use particular methods.
The registry states that the trial aimed to evaluate genetic influences on treatment response, but a genetic analysis and its result are not reported. The safety entries include event counts, but do not supply details about ascertainment, attribution, timing, or formal comparisons. Finally, enrollment of 143 does not establish the number included in each outcome analysis. The trial’s sample-size justification is not reported in the registry record; planning illustrations based on an observed effect are not a substitute for that prospective justification.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids — NCT01027143.
- Registry record last updated 2023-09-08; status last verified 2016-03.
- Results first posted 2023-09-08.
- 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
NCT01027143 is a completed randomized, quadruple-masked, parallel-group trial sponsored by Nemours Children's Clinic. The registry lists phases 2 and 3, enrollment of 143, a start of 2010-07, and primary completion on 2016-10-22. The study concerns asthma and obesity.
The intervention was omega-3 fatty acids, described as three EPA and DHA softgels twice daily; the control was soybean oil in three matched softgel capsules twice daily. The primary outcome was mean Asthma Control Questionnaire (Juniper) score, measured at baseline, 3 months, and 6 months. The record describes the scale as ranging from 0 to 6, with higher values indicating worse asthma control.
Numerical primary-outcome results, the genetic-response analysis, the statistical plan, and details of missing-data handling and analysis populations are not reported in the registry record. Safety entries list serious and other adverse events and deaths by group. Those entries are descriptive and do not provide a reported primary treatment-effect estimate.