Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder (NCT01694667), a randomized phase 2 study. The primary outcome is Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score.

2. Clinical Question

This is a question about a measured score over a defined follow-up period in a selected group of children, not a general test of omega-3 for all children with autism spectrum disorder. The planned comparison is between randomized groups; it does not by itself establish what would happen outside the trial population or over other durations. Interpretation depends on both the observed difference and its uncertainty, as well as on how the outcome was measured and analyzed. The registry record does not report the full eligibility criteria, the precise approach used to handle missing outcome measurements, or a detailed statistical analysis plan. Those details therefore cannot be used to extend the conclusion beyond the posted results.

3. Trial Design

The registry identifies this as a completed phase 2 randomized trial with a parallel-group design. It lists enrollment as 57. The posted primary outcome results include 29 participants in the omega-3 group and 28 in the placebo group. Random allocation is intended to make the groups comparable on average at the start of a study; it does not guarantee that every characteristic is balanced in a particular trial, and baseline group characteristics are not reported in the registry record.

The trial is described as quadruple masked in the design information. The study summary calls it double-blind and placebo-controlled, while the registry’s masking designation is quadruple. The record does not specify which participant, investigator, assessor, or other roles were masked, so the designation should not be expanded into assumptions about particular people or procedures. The active and placebo preparations were both orange-flavored pudding packets, and the placebo was described as matching the active preparation in appearance and taste.

The study summary describes an internet-based trial in which most procedures—including recruitment, consent, eligibility assessment, and collection of baseline and outcome measures—would take place over the internet. The primary outcome was change in hyperactivity score from baseline to 6 weeks. The primary timeframe also notes that a 3 week value was to be collected, but no 3 week result is posted as the primary result.

The registry lists the start as 2012-09 and primary completion as 2012-12, and the study status as completed. The sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, Inc. The original trial’s planned sample-size calculation, target effect, allocation details beyond randomization, and operational procedures beyond the summary 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: During the six-week recruitment period, 118 families expressed interest and completed the on-line screening form. Fifty-seven children from 28 states were deemed eligible and randomly assigned to study treatment.

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 Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score, measured over Baseline, 6 weeks (3 week value to be collected).

The primary endpoint was change in the Aberrant Behavior Checklist hyperactivity subscale score from baseline to 6 weeks. The scale is part of a 58-item survey whose items are rated from 0, indicating no problem, to 3, indicating a major problem. The hyperactivity subscale contains 16 items, and the total score ranges from 0 to 48. Higher scores indicate greater severity.

A change score expresses how much a participant’s measured score moved between the starting assessment and the later assessment. A negative change in this measure is a decrease in the recorded hyperactivity score; it does not, on its own, establish why that change occurred. Comparing mean changes between randomized groups focuses on whether the average movement differed between the assigned preparations.

This outcome was used to address the trial’s central question because the study targeted elevated hyperactivity and specified the ABC hyperactivity subscale as the primary measure. A standardized questionnaire can provide a consistent way to record behavior across participants and assessment times. However, a score is still a measurement of the construct defined by the scale, rather than a complete description of a child’s functioning. The registry record does not report additional validation details or the specific method used to collect and score each assessment. The listed primary timeframe is baseline to 6 weeks, with a 3 week value also noted for collection.

7. Results Posted in the Registry

• Omega-3: mean -5.30 versus -3.40 on control; difference -1.90 (95% CI -5.72 to 1.92), standardized effect d = -0.26; z-test p = 0.329.

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.

Change in Aberrant Behavior Checklist - Lethargy Subscale Score

• 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:
  • Omega-3: mean -2.10 versus 0.10 on control; difference -2.20 (95% CI -4.01 to -0.39), standardized effect d = -0.63; z-test p = 0.017.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Omega-3 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Aberrant Behavior Checklist - Stereotypy Subscale Score

• 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:
  • Omega-3: mean -2.00 versus -0.50 on control; difference -1.50 (95% CI -3.16 to 0.16), standardized effect d = -0.47; z-test p = 0.076.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Omega-3 and the control. The interval gives the range of effects that remain compatible with the data.

Aberrant Behavior Checklist - Irritability Subscale Score

• 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:
  • Omega-3: mean -2.00 versus -2.10 on control; difference 0.10 (95% CI -2.89 to 3.09), standardized effect d = 0.02; z-test p = 0.948.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Omega-3 and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists six secondary outcomes, but numerical results are posted for three of them. Those results include one comparison whose unadjusted interval does not include zero, one whose interval includes zero while leaning in the negative direction, and one estimate close to zero with an interval spanning both directions. This varied pattern does not form a uniform secondary-outcome signal. The registry record does not report numerical results for the other listed secondary outcomes, so their patterns cannot be assessed from the posted results.

These outcomes broaden the description of behavior beyond the primary hyperactivity measure, including other ABC subscales. They can provide context about whether the observed pattern on the primary measure appears alongside changes in other measured domains. They do not replace the primary comparison, and they should not be treated as independent confirmation of it. The outcomes are related measures collected in the same trial, so their results may not represent wholly separate evidence.

Secondary comparisons are unadjusted in the posted summaries, and the registry record does not report a multiplicity procedure. When several outcomes are examined, the chance of finding at least one apparently unusual result can increase, even if there is no true effect across the outcomes. A low unadjusted p-value on one secondary measure therefore carries less evidential weight than a result supported by a prespecified analysis that accounts for multiple testing.

The primary result itself is imprecise and its recalculated interval includes zero. Against that background, secondary findings are best viewed as exploratory descriptions rather than a resolution of the primary uncertainty. The registry record does not report a prespecified hierarchy among secondary endpoints, adjusted estimates, or confirmatory analyses. Conclusions about consistency across outcomes should remain cautious, especially because numerical results are absent for some listed outcomes.

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

• Change in Aberrant Behavior Checklist - Lethargy Subscale Score
• Change in Aberrant Behavior Checklist - Stereotypy Subscale Score
• Aberrant Behavior Checklist - Irritability Subscale Score
• Aberrant Behavior Checklist - Inappropriate Speech Subscale Score
• Change in Social Responsiveness Scale (SRS) Score
• Change in Clinical Global Impression - Improvement (CGI-I) Score

9. Statistical Interpretation

10. Statistical Methods Explained

For a continuous outcome, a group mean describes the average measurement or change among the participants represented in that group. The primary endpoint is a change score, so the means of -5.3 and -3.4 describe average movement from baseline to the recorded follow-up, rather than average follow-up scores. The mean difference of -1.9 is the contrast between those group averages, expressed in the scale’s units. It preserves the endpoint’s original measurement scale and can be read in relation to the score range and direction: higher scores indicate greater severity.

What does a standard deviation describe?

A standard deviation summarizes how spread out individual values are around a group mean. The primary outcome standard deviations are 7.2 for omega-3 and 7.5 for placebo. They describe variation among participants; they are not confidence limits for the group means and are not the same as the standard error. A relatively large spread means that participants’ changes vary considerably around the average. It is possible for group means to differ while individual observations overlap substantially.

The standard error describes the estimated sampling uncertainty of a statistic, such as a mean. The posted standard errors for the primary group means are 1.337 and 1.417. In general, a standard error tends to become smaller as the amount of information increases, although its value also depends on outcome variability and study design. It quantifies uncertainty in an estimated average, not the variation among individual participants. The registry does not report a model-based adjustment or covariates for the primary outcome.

How should the mean difference be read?

The reported comparison is the omega-3 group mean change minus the placebo group mean change. Thus, -1.9 means the omega-3 group’s average change was lower on the score scale by 1.9 units than the placebo group’s average change. Since negative changes indicate decreases from baseline, the direction can be described mathematically; it should not be translated into a clinical benefit without evidence about clinical importance and the study’s limitations. The registry record does not report a threshold for a clinically meaningful difference.

A confidence interval describes a range of values reasonably compatible with the data under the method used to calculate it. The recalculated interval is -5.719 to 1.919. Because it crosses zero, the data do not pinpoint the direction of the underlying average contrast. The interval is not a range containing a stated proportion of individual participants, nor does it assign a probability to the true effect. It is an estimate of uncertainty around the group comparison.

What does a p-value add?

The unadjusted p-value of 0.329 measures how unusual a result at least as extreme as the observed comparison would be under a statistical model in which the group means have no difference. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. A larger p-value is not proof that the groups are identical. The interval is useful alongside the p-value because it displays a range of compatible effect estimates.

The posted comparison is an unadjusted recalculation from the arm-level summaries. It does not incorporate a reported baseline-adjusted model or any other adjustment. Since the registry record lists no reported analyses for the secondary outcomes, the accompanying secondary comparisons should likewise be treated as unadjusted summaries rather than as results from a documented inferential model. The discrepancy indicator is false, so there is no reported discrepancy that would require giving a sponsor analysis precedence. Even so, the registry record does not provide a sponsor-reported primary inferential analysis to compare with the recalculation.

Why can outcome spread matter?

When measurements vary considerably among participants, a group mean may be estimated less precisely than it would be with less variability, all else equal. This is one reason that both the mean difference and its uncertainty matter. General statistical explanation: over-dispersion means that observations vary more than a model assumes. If an analysis assumes less variability than is present, its uncertainty estimates can be too small. The registry record does not report an over-dispersion assessment or a model that requires such an assessment; this concept is relevant as a general consideration, not as a claim about a problem detected in this trial.

Finally, the design and analysis details affect what can be inferred. Randomization supports a between-group comparison, while masking may reduce some sources of expectation or assessment bias. Neither feature removes uncertainty from a small study or resolves missing-data concerns. The registry record does not report the original statistical plan, interim analyses, analysis population definitions, or methods for missing outcomes. Those omissions restrict the ability to assess whether the posted summary matches the planned analysis in every respect.

11. Confidence Intervals and Precision

The primary mean difference is -1.9 units, with a recalculated unadjusted 95% confidence interval from -5.719 to 1.919. This interval is the central guide to precision: it spans values below and above zero, so the observed data do not settle whether the average contrast is negative or positive. The interval also includes values farther from zero than the point estimate, illustrating that the estimated difference is uncertain.

A confidence interval is not a prediction interval for individual children and does not say that a fixed proportion of individual changes lie between its limits. Rather, it reflects uncertainty in the estimated group contrast under the calculation’s assumptions. Its width depends on the amount of information and the variability in the outcome. The reported group standard deviations are 7.2 and 7.5, and the group results include 29 and 28 participants. These features help explain why the point estimate should not be treated as exact.

The unadjusted p-value is 0.329, which is consistent with the interval including zero. Neither statistic proves there is no difference. A result can be statistically inconclusive while still allowing potentially meaningful differences in either direction; whether any value is clinically meaningful cannot be determined because the registry record does not report a meaningful-change threshold.

The interval is recalculated from posted summary statistics and is not presented as a sponsor-reported confidence interval. The discrepancy indicator is false. The registry record does not report a sponsor analysis of the primary contrast, so no sponsor interval or adjusted estimate is available for comparison. Precision should therefore be understood as that of the unadjusted summary comparison, not as a complete account of every possible analysis.

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 80% power and participants per arm for 90% power. They are not total events, since this is a continuous outcome rather than a time-to-event outcome. The calculations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They take the observed effect as a starting point and illustrate detecting the stated fraction of that observed effect.

The 80% power column represents a planning target under which a study with the listed participants per arm would have an 80% chance of detecting the assumed effect at the stated significance level, if the calculation’s assumptions hold. The 90% power column uses a higher chance of detecting that assumed effect and consequently lists larger sample sizes. These are design illustrations, not results from the trial’s actual design process. They are not observed power.

Rows that plan for 75% or 50% of the observed effect assume a smaller effect than the row based on 100% of the observed effect. Smaller effects are harder to distinguish from sampling variation, so more participants per arm are required to reach the same power target. The figures can help readers understand how sensitive planning requirements are to the effect size chosen, but they do not establish that the observed effect is stable or that a future study will reproduce it.

The registry record does not report the trial’s own original sample-size justification or planning assumptions. The posted illustrations therefore should not be read as evidence that the study was designed with these targets, nor as proof that it had adequate power for the primary or secondary outcomes. The observed enrollment and the planning illustrations answer different questions: one reports the trial’s enrollment, while the other describes hypothetical requirements under specified assumptions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -1.900; pooled standard deviation σ = 7.349.
2. n = 2 × (1.96 + 0.842)² × 7.349² / -1.900² = 234.8, rounded up to 235 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1.9                      # observed difference in means
sigma <- 7.34880324208705                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1694667)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 235 (80% power), 315 (90% power)
 75% of observed effect: n per arm = 418 (80% power), 559 (90% power)
 50% of observed effect: n per arm = 940 (80% power), 1,258 (90% power)
power.t.test: 235.8 
Simulated power at n = 235 per arm: 0.803 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple outcome measures: one primary measure and six secondary outcomes. It does not report a multiplicity adjustment, a testing hierarchy, or another method for controlling the chance of false-positive findings across the outcomes. Without such information, the reported secondary p-values should be regarded as unadjusted. A nominal result from one of several comparisons is less persuasive on its own than a result from a single prespecified primary test, because repeated testing creates more opportunities for chance findings.

The record also does not report whether any interim analyses were conducted, whether outcome analyses were prespecified in a detailed statistical analysis plan, or how the final analysis population was defined. The randomized design is stated, but an intention-to-treat definition or another population rule is not reported in the registry record. The listed group counts describe the participants included in the posted outcome summaries; they do not establish what inclusion or exclusion rules were used for each analysis.

Missing-data methods are not reported in the registry record. It is therefore not possible to determine whether missing follow-up measurements occurred, how much information was missing, or whether any imputation or sensitivity analysis was used. This matters because a change score requires information at the relevant assessments, and the handling of incomplete measurements can affect group estimates if missingness is related to outcomes or treatment assignment.

These missing details limit assessment of the analysis process, but they do not demonstrate that a particular bias occurred. They identify uncertainties that cannot be resolved from the registry record. The appropriate interpretation is to describe the posted results as unadjusted summaries and avoid assuming that unreported procedures were or were not performed. Further analysis detail would be needed to evaluate multiplicity control, missing-data assumptions, and the relationship between the planned and reported analyses.

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.

Most frequent non-serious adverse event terms

The serious adverse event figures report zero participants with a serious adverse event attributed in the omega-3 group and zero in the placebo group. The corresponding groups at risk are listed as 29 and 28. This is a count of reported serious events attributed in the registry, not evidence that no serious event of any kind occurred during the study.

The record lists other adverse events for 10 participants in the omega-3 group and 6 in the placebo group, among 29 and 28 at risk, respectively. These are reported separately from serious adverse events. The registry record does not provide event terms in the posted summary, so the types and severity of these other events cannot be described from these figures alone.

Death counts are not reported in the registry record. The absence of listed serious adverse event terms and the zero attributed counts should not be interpreted as proof of no risk. These figures are descriptive counts from a trial with the listed group sizes and follow-up; they do not establish comparative safety for other populations, durations, or settings.

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

The result describes mean change in a specified behavioral scale over a 6 week period among children ages five through eight with autism spectrum disorder and elevated hyperactivity. Both groups had negative average changes, and the omega-3 group’s average change was lower than the placebo group’s by 1.9 units. The recalculated unadjusted confidence interval includes zero, so the primary comparison remains uncertain in direction and size.

This does not establish that the preparations have identical effects. It also does not establish that omega-3 causes a difference in the measured score. The interval is compatible with a range of possible contrasts, and the registry record does not report a threshold for clinical importance. A difference on a questionnaire scale cannot automatically be translated into a meaningful change in daily functioning.

The trial’s setting and population matter. The stated target group was children ages five through eight with autism spectrum disorder and elevated baseline hyperactivity. These results do not, by themselves, apply to children outside those criteria, other age groups, people without elevated hyperactivity, or other outcomes and durations. The study summary describes procedures conducted largely over the internet, but the record does not establish how results would generalize to different assessment settings.

The secondary outcomes offer additional measurements, but their unadjusted nature and incomplete numerical reporting limit their role in confirming the primary result. The registry record also does not report missing-data methods, analysis-population definitions, or the trial’s detailed statistical plan. These gaps constrain interpretation of the posted summaries.

Accordingly, the data support a cautious description of observed group averages and uncertainty, not medical advice or a broad conclusion about treatment effectiveness. They do not determine the effect for an individual child, the mechanism behind any score change, or the likely result of a future study. Such questions require evidence beyond these posted registry results.

17. Why This Trial Matters Statistically

This trial illustrates why a group mean and a p-value are not enough to characterize a clinical result. The primary estimate is a mean difference of -1.9, but the confidence interval ranges from -5.719 to 1.919. The point estimate gives a concise contrast, while the interval shows that the estimate is not precise enough to establish the direction of the underlying average difference.

The distinction between a non-significant comparison and evidence of equivalence is especially important. The primary p-value is 0.329, but that does not prove that the treatments have the same effect. An equivalence conclusion would require a prespecified margin and an analysis designed for that question; neither is reported in the registry record. The observed uncertainty should not be converted into a definitive claim of no difference.

The secondary outcomes also show why multiple testing matters. A trial may assess several related measures, and an unadjusted signal among them can arise by chance. Without a reported multiplicity plan, secondary results are less compelling as confirmatory evidence. This is a design and interpretation issue, not a reason to disregard the measurements entirely; they can still describe the broader pattern and inform future hypotheses.

Finally, the trial separates observed results from planning illustrations. Sample-size scenarios based on the observed effect help show how assumptions about effect size influence future planning, but they are not evidence of the trial’s original design adequacy or its observed power. The registry record does not report the original sample-size justification. Taken together, the study is a useful example of reporting a point estimate, uncertainty, secondary measures, and planning scenarios while also showing why missing analysis details temper conclusions.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary comparison is based on posted group summaries, and its recalculated unadjusted confidence interval includes zero. The result is therefore uncertain, and the registry record does not provide a sponsor-reported inferential analysis or adjusted estimate for comparison. The discrepancy indicator is false, but the available summary still does not document every aspect of the analysis.

The record does not report the original sample-size calculation, the intended effect size, or the trial’s statistical analysis plan. It also does not report analysis populations, missing-data procedures, interim analyses, or multiplicity adjustment. These omissions prevent a full assessment of whether the analysis followed prespecified methods and how incomplete follow-up, if any, was handled. They should be treated as unreported details, not evidence that a specific problem occurred.

Numerical secondary results are posted for only three of the six listed secondary outcomes. The unadjusted secondary results should be interpreted cautiously, particularly because several outcomes were measured and no multiplicity procedure is reported. The registry does not provide a clinically meaningful threshold for the primary score, limiting interpretation of the size of the mean difference in practical terms.

The study targeted a defined age range and children with elevated hyperactivity. Its conclusions cannot automatically be extended to other populations, ages, or follow-up periods. The primary outcome is a questionnaire subscale, and the record does not report additional information that would connect score changes to broader functioning. The summary’s internet-based procedures may also make the study context distinctive, although the registry record does not provide enough detail to quantify any effect of setting on results.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder — NCT01694667.
• Registry record last updated 2020-08-31; status last verified 2020-08.
• Results first posted 2014-06-16.
• 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

The registry describes a completed, randomized, quadruple-masked, parallel phase 2 trial comparing omega-3 fatty acids with placebo in children with autism spectrum disorder and elevated hyperactivity. The study summary describes an internet-based approach and identifies change in ABC hyperactivity score from baseline to 6 weeks as the primary outcome.

The posted primary means were -5.3 for omega-3 and -3.4 for placebo, with a mean difference of -1.9. The recalculated unadjusted 95% confidence interval, -5.719 to 1.919, includes zero; the unadjusted p-value is 0.329. The result is therefore imprecise and does not establish a clear group difference.

Some secondary results and adverse-event counts are posted, but secondary analyses are unadjusted and several analysis details are not reported in the registry record. The results should be interpreted as summaries for the stated population, measures, and follow-up, not as a definitive conclusion about effects beyond them.