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 Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients (NCT01826422), a randomized na study. The primary outcome is Body Composition (Body Fat).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01826422 |
| Phase | NA |
| Condition | Muscular Dystrophy, Duchenne |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Coordinación de Investigación en Salud, Mexico |
| Results posted | Yes |
2. Clinical Question
Population
The registry record identifies Duchenne muscular dystrophy as the condition. Its study summary describes patients with Duchenne muscular dystrophy or Becker muscular dystrophy, so the intended population in the summary includes both diagnoses. The record does not report how many participants had each diagnosis or give further eligibility details.
Intervention
The intervention was EPA and DHA supplementation. The arm description specifies 2.7 g/d in 10 capsules per day over 6 months. The study summary describes the supplementation as intended to address inflammation, muscular regeneration, and metabolic disorders.
Comparator
The comparator was sunflower oil, described as a placebo, at 2.7 g/d in 10 capsules per day over 6 months. Both arms were therefore described as receiving capsules on the same daily schedule, although further details about the placebo and adherence are not reported in the registry record.
Primary question
The primary endpoint was body composition, expressed as body fat in g/Kg of body weight. It was assessed by Dual X-ray Absorptiometry at baseline and at months 3 and 6 of supplementation. The clinical question is whether body-fat measurements changed over those assessments in the EPA and DHA arm compared with the placebo arm. The registry record does not report the numerical endpoint results or a treatment-effect estimate, so the comparison cannot be quantified from the posted results.
The registry record describes a randomized, quadruple-masked, parallel-group study, with enrollment of 40. It lists the trial as completed. These design features define the planned comparison, but they do not establish what the endpoint results were. In particular, the body-fat measurement schedule alone does not say whether either group changed, whether changes differed between groups, or how uncertain a between-group estimate would be.
3. Trial Design
This was a randomized, parallel-group trial comparing EPA and DHA supplementation with a sunflower-oil placebo. The registry record identifies the masking as quadruple. It does not explain which people or roles were masked, how masking was maintained, or how the random sequence was generated or concealed. Those implementation details are not reported in the registry record.
The record lists enrollment of 40 and a completed status. It gives March 2013 as the study start and January 2017 as the primary completion date. The listed phase is NA. The sponsor is Coordinación de Investigación en Salud, Mexico. The registry condition is Duchenne muscular dystrophy, while the brief study summary describes patients with Duchenne or Becker muscular dystrophy. The distribution of diagnoses among enrolled participants is not reported in the registry record.
The intervention description specifies EPA and DHA at 2.7 g/d in 10 capsules per day for 6 months. The placebo arm is described as sunflower oil at 2.7 g/d, also in 10 capsules per day for 6 months. The stated schedule was 4 capsules in the morning, 3 in the afternoon, and 3 at night. The registry record does not report adherence, treatment discontinuation, or the number of participants who completed each assessment.
The primary outcome was body composition, specified as body fat in g/Kg of body weight and measured by Dual X-ray Absorptiometry. Assessments were planned at baseline and at months 3 and 6 of supplementation. The record also names inflammation biomarkers, inflammation-related expression measures, and creatinine kinase as secondary outcomes. The analysis methods for these outcomes, and the planned primary comparison across assessment times, 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
| Stage | EPA and DHA | Sunflower Oil |
|---|---|---|
| STARTED | 18 | 22 |
| COMPLETED | 17 | 19 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | EPA and DHA | Sunflower Oil |
|---|---|---|
| Withdrawal by Subject | 1 | 3 |
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 | EPA and DHA | Sunflower Oil | Total |
|---|---|---|---|---|
| Participants analysed | 17 | 19 | 36 | |
| Age, Categorical: <=18 years | Participants | 17 | 19 | 36 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 7.3 (SD 3.1) | 8.6 (SD 2.9) | 8.1 (SD 2.9) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 17 | 19 | 36 |
| Region of Enrollment: Mexico | participants | 17 | 19 | 36 |
6. Primary Endpoint
The registry lists the primary outcome as Body Composition (Body Fat), measured over At baseline and at months 3 and 6 of supplementation..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | g/Kg of body weight |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns body composition, specifically body fat expressed in g/Kg of body weight. The registry record says body composition was assessed using Dual X-ray Absorptiometry, or DXA, at baseline and at months 3 and 6 of supplementation. It specifies the summary format as a median with a full range. The record does not give the actual medians or ranges for either arm at any assessment.
Body composition is relevant to the study’s stated interest in metabolic disorders, including obesity. The study summary also identifies inflammation and muscular regeneration as areas of interest, but those are not the named primary endpoint. The body-fat measure provides a defined outcome for describing participants’ body composition; it should not be treated as a direct measurement of every metabolic process named in the study summary.
Repeated assessment can describe how measurements vary over the study period and how the arms compare at specified times. A treatment comparison requires the observed values and a clearly specified analysis, including how baseline measurements and follow-up measurements were handled. Neither outcome values nor a statistical estimate for the primary comparison is reported in the registry record. Consequently, the endpoint definition explains what was intended to be measured, but does not establish the direction, size, or precision of any observed difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record provides a clear description of the intended primary outcome and the intervention schedule, but it does not report numerical primary-outcome results. There are no body-fat medians, full ranges, between-arm estimates, confidence intervals, or significance tests in the posted results. The central statistical question—how body-fat measurements compared between EPA and DHA and placebo—therefore cannot be answered from the information reported.
This absence matters because the outcome was assessed at baseline and at months 3 and 6. Measurements at more than one time point can be described in several ways: as values at each visit, as changes from baseline, or through a model that uses all available measurements. These approaches answer related but not identical questions. The registry record does not identify which primary contrast or longitudinal method was used. It would be inappropriate to select one after the fact or to infer an effect from the study title or stated purpose.
The record specifies medians and full ranges. A median describes the middle of an ordered set of measurements, while a full range gives its minimum and maximum. These summaries can describe a distribution without assuming that values follow a symmetric, bell-shaped pattern. However, medians and ranges alone do not quantify uncertainty in a treatment comparison. In particular, they do not provide a confidence interval for the difference between arms. No such interval is reported in the registry record.
The study was randomized, which is intended to support a fair comparison by allocating participants without choosing their treatment based on their characteristics. Randomization does not guarantee that the groups were identical in every respect, especially in a trial of this enrollment size, and it does not replace reporting the outcomes. The randomization procedure and baseline outcome summaries are not reported in the registry record, so the balance of the groups cannot be evaluated from the posted information.
The record lists 40 enrolled participants, but it does not report the number contributing primary-outcome data at each visit or the reasons for any missing measurements. Without that information, readers cannot judge how complete the body-fat data were or whether the reported analysis, if any, included all randomized participants. The result is not simply imprecise; the primary comparison itself is not numerically reported in the registry record.
Safety counts are reported separately. Serious adverse events were recorded for zero participants in each arm; other adverse events were recorded for one participant in the EPA and DHA arm and zero in the sunflower-oil arm, with zero deaths in both arms. These counts describe recorded events in the stated groups. They do not supply the missing primary efficacy estimate, nor do they establish that an event was or was not caused by treatment.
Overall, the posted information supports a description of the trial design, endpoint, and recorded adverse-event counts. It does not support an estimate of the direction or magnitude of the primary treatment effect, a judgment about its precision, or a conclusion about the secondary outcomes. Those quantities are not reported in the registry record.
9. Statistical Methods Explained
The methods needed to interpret a trial result depend on both the outcome’s scale and the comparison the investigators intended to make. The registry record identifies body fat in g/Kg of body weight as the primary outcome, reports a median and full range as its summary format, and gives assessments at baseline and at months 3 and 6. It does not report the statistical test, model, or exact primary contrast. The explanations below describe general statistical concepts; they do not establish which method was used in this trial.
What does a median and full range describe?
In general, the median is the middle value when observations are ordered. It is less influenced by unusually high or low observations than the arithmetic mean. A full range records the lowest and highest observed values, giving a sense of the span of the data. The range is also sensitive to extreme observations and does not show how values are distributed between the endpoints. These summaries are descriptive: they help characterize observed measurements, but do not by themselves establish whether the arms differ beyond what might be expected from sampling variability.
When an outcome is summarized by medians, a comparison can focus on distributions or on a difference in a suitable location measure. Different methods make different assumptions and may target different quantities. A difference between reported medians is not automatically the same as a model-based treatment effect. The record does not report a test or estimator for the primary endpoint, so no particular interpretation of an unreported comparison should be assumed.
Why does the assessment schedule matter?
Repeated measurements from the same participant are related: a participant’s measurements over time are not generally independent observations. A method that treats every measurement as unrelated can misstate uncertainty. General approaches for repeated data account for within-participant correlation, or define a specific comparison at a particular visit. Some analyses compare follow-up values while adjusting for baseline; others analyze changes from baseline or model the trajectory over time. These strategies can yield different estimates, especially if data are incomplete or if the pattern of change is not adequately represented by the model.
The registry record names baseline, month 3, and month 6 assessments, but it does not report whether the main question was a difference at month 3, a difference at month 6, an overall pattern across visits, or another contrast. It also does not state how baseline measurements entered the analysis. Therefore, the schedule alone is insufficient to reconstruct the estimand—the specific treatment effect the analysis was meant to estimate.
What would a confidence interval add?
In general, a confidence interval gives a range of values compatible with the data and the assumptions of the analysis. Its width communicates precision: a narrower interval indicates a more precise estimate, while a wider interval indicates greater uncertainty. The point estimate and interval should be read together. A statistical test or p-value, on its own, does not show the size of an effect or the range of plausible values. No primary treatment estimate, confidence interval, or p-value is reported in the registry record, so the precision of the primary comparison cannot be assessed.
Why can over-dispersion matter?
In general, over-dispersion occurs when the variability in data is greater than a statistical model assumes. If a method assumes less variability than is present, its standard errors may be too small and its uncertainty estimates too optimistic. For a continuous body-fat measure, relevant concerns include the distribution of measurements, outlying values, and the dependence among repeated measurements. The registry record does not report a distributional assessment, model diagnostics, or a method for handling unusual observations. There is no basis for saying that over-dispersion was present in this trial; it is a general consideration when evaluating model assumptions.
What does randomization contribute?
In general, random allocation is intended to make treatment assignment independent of participants’ measured and unmeasured characteristics. This supports a causal comparison when the assigned groups are analyzed appropriately and outcome data are available. Chance imbalances can still occur, and losses to follow-up or deviations from assigned treatment can complicate interpretation. The record identifies the study as randomized, but the sequence-generation method, concealment procedure, analysis population, and handling of treatment changes are not reported in the registry record.
The registry record describes the study as quadruple-masked. Masking can reduce the risk that knowledge of assignment influences behavior, outcome assessment, or analysis, depending on who is masked and how masking is maintained. The record does not identify the masked roles or report whether masking was tested or maintained. The design label is informative, but does not answer those implementation questions.
Finally, outcome analysis is only one part of the evidence needed for interpretation. The number analyzed at each visit, the approach to missing measurements, the prespecified analysis plan, and any sensitivity analyses can affect confidence in a result. These details are not reported in the registry record. As a result, general statistical principles can explain what would be needed to interpret the endpoint, but cannot fill in the missing trial-specific analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 20 outcome measures and 20 analyses. It names secondary outcomes involving TNF-A, IL-1, IL-6, and IL-10 inflammation biomarkers; IL-6, TNF-A, and IL-1 expression; and creatinine kinase as a marker of muscle degeneration. The primary endpoint also has assessments at baseline and at months 3 and 6. Considering several outcomes, time points, or contrasts can create a multiplicity problem: the more comparisons examined, the greater the chance that an apparently notable finding occurs by chance if each is judged separately.
In general, multiplicity can be addressed by defining a primary contrast in advance, adjusting statistical inference for a family of comparisons, or clearly presenting secondary and exploratory analyses as such. The appropriate approach depends on the research questions and analysis plan. The registry record does not report a multiplicity adjustment, hierarchy among secondary outcomes, or which comparisons were designated confirmatory. It is therefore not possible to determine how the reported analyses, if any, accounted for multiple testing.
Missing-data handling is also not reported in the registry record. The record gives enrollment of 40 and safety groups of 18 and 22, but does not state the number with primary-outcome data at each assessment, reasons for missing data, or the method used to handle missing measurements. General approaches may use available observations under stated assumptions, model missing outcomes, or examine alternative assumptions in sensitivity analyses. These methods are not interchangeable, and no specific one can be attributed to this trial.
The analysis populations are not described. The record does not say whether the primary analysis included all randomized participants, only those who completed treatment, or another defined group. It also does not report how treatment nonadherence or withdrawal was handled. Without a prespecified analysis population and accounting of participants across visits, readers cannot assess whether the analysis preserved the intended randomized comparison or how missingness might affect the result.
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 |
|---|---|---|---|
| EPA and DHA | 0 | 18 | 0.0% |
| Sunflower Oil | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| EPA and DHA | 0 of 18 |
| Sunflower Oil | 0 of 22 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| EPA and DHA | 1 of 18 |
| Sunflower Oil | 0 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | EPA and DHA | Sunflower Oil |
|---|---|---|---|
| Vomiting and diarrhea | Gastrointestinal disorders | 1 of 18 | 0 of 22 |
The registry record reports serious adverse events for 0 of 18 participants at risk in the EPA and DHA group and 0 of 22 participants at risk in the sunflower-oil group. It reports other adverse events for 1 of 18 participants at risk in the EPA and DHA group and 0 of 22 in the sunflower-oil group. Deaths were reported for 0 participants in each group. These are counts of participants with recorded events, not estimates of the primary body-fat outcome.
Zero recorded serious adverse events means that none were counted in the stated groups during the period represented in the record. It does not prove that serious events cannot occur, and it does not establish equivalence in safety between the groups. With no event in a group, the data still leave uncertainty about the range of event frequencies compatible with the observation. The record does not report event definitions, observation duration for safety, how events were collected, or whether any events led to treatment discontinuation.
The other-adverse-event count is small in the record, but the event term is not specified. The record also does not state whether an event was considered related to the assigned intervention. The counts should therefore be read as descriptive registry information, not as a causal assessment or a complete characterization of safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel-group trial compared EPA and DHA supplementation with sunflower-oil placebo and specified body fat as its primary endpoint. It also records the intervention schedule, assessment times, and adverse-event counts. These details help define the question the trial was intended to address.
What the record does not establish is the primary outcome result. It contains no numerical body-fat summaries or treatment-effect estimate at baseline, month 3, or month 6. There is consequently no reported basis for saying whether body fat differed between groups, by how much, in which direction, or with what precision. The absence of those results should not be interpreted as evidence of no difference; it means the comparison is not reported in the registry record.
The study summary describes an interest in inflammation, muscular regeneration, obesity, and insulin resistance. The listed secondary outcomes include inflammation biomarkers and expression measures, along with creatinine kinase. The presence of these outcomes in the record does not tell readers what their values were or whether any differed between groups. Their results are not reported in the registry record.
The safety counts provide limited descriptive information: no serious adverse events or deaths were recorded in either group, and one other adverse event was recorded in the EPA and DHA group versus zero in the sunflower-oil group. Because event definitions, relatedness assessments, and fuller follow-up details are not reported, these counts do not determine comparative safety.
In general, randomized designs are intended to support fair treatment comparisons, but the quality of an inference also depends on outcome reporting, follow-up, analysis methods, and missing-data handling. Those details are not reported sufficiently to reconstruct the primary analysis. The appropriate reading is therefore bounded: the record documents the study design and some safety counts, while the central efficacy result and its uncertainty remain unavailable in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between a registered research question and a reported treatment result. The record defines the intervention, comparator, primary endpoint, and assessment schedule. Those elements make the intended comparison understandable. Yet without the observed endpoint summaries and an estimate of the between-group contrast, the magnitude and precision of the primary result cannot be evaluated.
The endpoint is measured repeatedly, which raises a practical statistical question: how should measurements from the same participants over time be used? The answer depends on the target comparison and analysis method. A result at a particular follow-up visit, an overall trajectory, and a change-from-baseline contrast are different summaries of the data. The registry record does not specify which was used, underscoring why a clearly stated estimand and analysis plan matter for interpretation.
The record also names several secondary outcomes and reports 20 outcome measures and 20 analyses. When a study considers multiple outcomes and time points, readers need to know how confirmatory questions were distinguished from exploratory ones and whether multiplicity was addressed. Those details are not reported in the registry record. This is relevant because a collection of separate findings can be harder to interpret than a prespecified primary comparison.
Finally, the reported safety counts show why denominators and event definitions matter. Counts without detailed follow-up, event descriptions, and a clear account of ascertainment provide only a limited view. This trial is statistically instructive not because its unreported efficacy result can be inferred, but because it shows how design information, outcome definitions, analysis details, and complete results each contribute distinct parts of a reliable interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation for interpreting the primary question is that numerical body-fat results are not reported in the registry record. There are no medians, full ranges, or treatment-effect estimates for the listed assessment times. The record therefore does not permit an assessment of effect direction, magnitude, or precision.
The primary endpoint is scheduled at baseline and at months 3 and 6, but the exact comparison and analysis method are not reported. It is unclear whether the intended primary inference concerned a specific follow-up assessment or a pattern over time. The record also does not describe the method used to account for repeated measurements or baseline values.
Participant flow and analysis populations are not reported. Although enrollment is listed as 40, the record does not state how many participants contributed primary-outcome data at each visit, whether all randomized participants were analyzed, or why any data were missing. Adherence, treatment discontinuation, and protocol deviations are also not described.
Further design and analysis details are absent, including the randomization procedure, concealment, identities of the masked groups, prespecified statistical plan, multiplicity approach, and sensitivity analyses. The record lists secondary outcomes and 20 outcome measures and analyses, but does not report their numerical findings or clarify which comparisons were confirmatory.
The registry condition is Duchenne muscular dystrophy, while the brief summary describes patients with Duchenne or Becker muscular dystrophy. The number and outcomes of participants in each diagnostic group are not reported. Safety information is limited to event counts; definitions, descriptions of the other adverse event, relatedness, and detailed follow-up are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients — NCT01826422.
- Registry record last updated 2018-03-09; status last verified 2018-02.
- Results first posted 2018-02-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed randomized, quadruple-masked, parallel-group trial with enrollment of 40. It compares EPA and DHA supplementation with sunflower-oil placebo. Both arm descriptions specify 2.7 g/d in 10 capsules per day for 6 months. The registry lists Duchenne muscular dystrophy as the condition; the brief summary also refers to Becker muscular dystrophy.
The primary endpoint is body fat in g/Kg of body weight, assessed by DXA at baseline and at months 3 and 6, with medians and full ranges specified. The record does not report numerical primary-outcome results, a treatment-effect estimate, or its uncertainty. It lists inflammation biomarkers, expression measures, and creatinine kinase among the secondary outcomes, but does not report their results.
Serious adverse events and deaths were recorded for zero participants in both groups. Other adverse events were recorded for one participant in the EPA and DHA group and zero in the sunflower-oil group. Further event details and the statistical analysis methods are not reported in the registry record.