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 Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH) (NCT00845845), a randomized phase 2 study. The primary outcome is Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00845845 |
| Phase | Phase 2 |
| Condition | Nonalcoholic Steatohepatitis (NASH), Hepatic Steatosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Illinois Chicago |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with nonalcoholic steatohepatitis (NASH), with hepatic steatosis also listed among the conditions. The secondary-outcome description refers to patients with biopsy-proven NASH. Other eligibility details, such as age range, disease severity criteria, and exclusions, are not reported in the registry record.
Intervention
Participants assigned to the active-treatment arm received 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks. The study summary describes the supplementation as omega-3 fatty acid supplementation and identifies the study as a pilot assessing magnetic resonance imaging (MRI) for quantifying hepatic steatosis.
Comparator
The comparison arm received daily placebo and dietary counseling for 24 weeks. Thus, the registered contrast concerns the addition of Lovaza versus placebo in the setting of dietary counseling; it is not a comparison of counseling with no counseling.
Primary question
The primary-outcome title concerns omega-3 fatty acid supplementation and its effect on hepatic steatosis and other factors associated with NASH development, with a timeframe of 24 weeks. The registry record does not specify a single primary measurement, its unit, or a statistical parameter. Because primary analyses were never completed, the record does not establish whether the intervention changed the registered outcomes.
3. Trial Design
This was a phase 2, randomized, quadruple-masked, parallel-group study sponsored by University of Illinois Chicago. The registry lists enrollment of 12. Participants were assigned to omega-3-acid ethyl esters (Lovaza) or placebo; both groups also received dietary counseling for 24 weeks. The masking designation is recorded as quadruple, but the identities of the people or roles who were masked are not reported in the registry record. Details of the random sequence generation and allocation concealment are also not reported.
The study start is recorded as 2006-03, and primary completion is recorded as 2010-10. The status is terminated. The primary-outcome description states that the study was terminated on October 12, 2010 due to low enrollment and that primary analyses were never completed. The record therefore documents a planned randomized comparison, but not a completed primary efficacy analysis.
The study summary describes MRI assessment of hepatic steatosis as a pilot objective, intended to provide preliminary data regarding omega-3 fatty acid supplementation. The secondary-outcome listing specifically identifies MRI as an assessment of hepatic steatosis in patients with biopsy-proven NASH. The registry lists two outcome measures, but does not report completed primary analyses. Further operational details—including the treatment adherence approach, how dietary counseling was standardized, and the timing of assessments beyond the stated 24-week timeframe—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: A screening evaluation was used prior to group assignment to evaluate whether patients were affected by nonalcoholic steatohepatitis (NASH) and to evaluate the inclusion and exclusion criteria.
Overall Study
| Stage | Omega-3-acid Ethyl Esters (Lovaza) | Placebo |
|---|---|---|
| STARTED | 3 | 6 |
| COMPLETED | 3 | 2 |
| NOT COMPLETED | 0 | 4 |
Reasons for not completing this period:
| Reason | Omega-3-acid Ethyl Esters (Lovaza) | Placebo |
|---|---|---|
| Lost to Follow-up | 0 | 4 |
Analysis population for the primary outcome, as defined in the registry: This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.
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-acid Ethyl Esters (Lovaza) | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 6 | 9 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 | 6 | 9 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 2 | 2 | 4 |
| Sex: Female, Male: Male | Participants | 1 | 4 | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 | 4 | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 3 | 6 | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH), measured over 24 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The registered primary outcome is titled around omega-3 fatty acid supplementation and its effect on hepatic steatosis and other factors associated with NASH development, with assessment at 24 weeks. This framing identifies the clinical topic and timing, but does not define one specific endpoint. The registry record gives no unit, parameter, or further description for the primary measure. It therefore does not say whether the main outcome was a continuous measurement, a categorical assessment, or a collection of measures, nor does it identify a single value to use for an effect estimate.
The study summary says MRI was being assessed as a method to quantify hepatic steatosis. MRI is also named in a secondary outcome concerning assessment of hepatic steatosis in patients with biopsy-proven NASH. In general, a quantitative measure can help describe changes in a target characteristic, but the interpretation depends on how the measure is defined, collected, and analyzed. Those details are not reported in the registry record.
The registry’s endpoint description states that primary analyses were never completed. Consequently, no primary outcome estimate or uncertainty interval is reported. The endpoint’s intended clinical subject and timeframe are identifiable, but its exact statistical definition and observed result are not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of Lovaza plus dietary counseling against placebo plus dietary counseling. It records enrollment of 12 and a planned 24-week timeframe. However, the trial status is terminated, and the primary-outcome description explicitly says that low enrollment led to termination and that primary analyses were never completed. These details are central to interpretation: the record does not report an analyzed primary outcome, an estimated treatment contrast, or a confidence interval for that contrast.
Accordingly, the registry does not show whether hepatic steatosis or the other factors named in the primary-outcome title differed between the groups. It also does not establish whether any apparent difference would be compatible with no effect or with effects of potentially different sizes. In general, an estimate describes the direction and magnitude of a comparison, while a confidence interval conveys uncertainty around that estimate. Neither is reported for the primary outcome. The lack of a completed analysis is not evidence that the treatments were equivalent, and it is not evidence that one was superior.
The listed MRI outcome may indicate the kind of assessment the investigators intended to explore, but a registered outcome is not itself a result. No completed MRI comparison or other efficacy result is reported in the registry record. The primary outcome is not reduced to one comparison because it is described as involving hepatic steatosis and other factors; the exact measures and their analyses are not reported. The outcome count alone cannot fill in those missing specifications.
The adverse-event figures are a separate part of the record and should not be read as an efficacy analysis. They describe the at-risk groups and affected participants for serious and other adverse events. The registry lists one participant with a serious adverse event in the Lovaza group and none in the placebo group, and it lists other adverse events in the Lovaza group but none in the placebo group. Given the small at-risk groups and the absence of a completed primary analysis, these counts are descriptive. They do not support a stable comparative estimate of risk.
Planning illustrations based on an observed effect are not a substitute for a completed primary analysis, and they do not establish the study’s original design rationale. The record does not report a sample-size justification. Nor should a planning calculation be interpreted as observed power or as evidence of treatment effect. The most defensible conclusion is that the registry documents the study question, design, termination, and limited adverse-event counts, but not a completed primary efficacy result.
9. Statistical Methods Explained
Randomization is intended to assign participants to study groups by chance, helping reduce systematic differences between groups at the point of assignment. This registry identifies the trial as randomized, but does not report how the random sequence was generated, whether assignment was concealed before enrollment, or how randomization was implemented. Those details matter when assessing how well the design could protect against selection bias, but they cannot be inferred from the word “randomized” alone.
The study is described as quadruple-masked. Masking can reduce the influence of expectations on treatment delivery, participant reports, and outcome assessment. The registry record does not identify which roles were masked or describe whether the mask was maintained. The parallel model means the registered design compared groups receiving their assigned interventions over the stated 24-week period, rather than describing a crossover comparison. Both arms included dietary counseling, so the intended contrast was Lovaza versus placebo alongside that counseling.
The primary outcome is not sufficiently specified for a statistical reconstruction. Its title refers to hepatic steatosis and other factors associated with NASH development, but the unit, parameter, and detailed measurement description are absent. General statistical practice requires a clearly defined outcome and comparison before an effect estimate can be interpreted. For a continuous endpoint, an analysis might report a difference in group means; for a categorical endpoint, it might report a difference in proportions or another measure. These are general possibilities, not descriptions of analyses used in this trial. The registry does not identify which form applies to the primary outcome.
A confidence interval is a way to express the statistical uncertainty around an estimate. A narrow interval generally indicates greater precision than a wide interval, while an interval spanning a range of plausible effects indicates that the data do not pin down the effect precisely. A p-value, when reported, addresses compatibility of the data with a specified statistical model and null hypothesis; it does not measure the size or clinical importance of an effect. No primary estimate, confidence interval, or p-value is reported in the registry record, because the primary analyses were never completed.
In general, analyses should be matched to the outcome’s scale, distribution, and study design. Measurements that are highly skewed, contain many zeros, or vary more than a simple model expects may require methods that account for those features. Over-dispersion, for example, means that observed variability exceeds what a model assumes; ignoring it can make uncertainty appear too small. These are general methodological considerations only. The registry does not report a statistical analysis plan, model choice, distributional assessment, covariate adjustment, or handling of repeated measurements for this study.
The record lists two outcome measures and zero analyses. The primary-outcome description says that primary analyses were never completed. A registered outcome indicates what investigators intended to assess, not that the measurement was collected or analyzed. Likewise, the presence of an MRI-related secondary outcome does not establish that MRI data were available or that a comparison was performed. The record does not report outcome-specific participant counts, missing-data methods, or whether analyses were planned according to assigned treatment.
The sample-size assumptions associated with planning illustrations describe a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the target effect is described as a stated fraction of the observed effect. These assumptions characterize planning illustrations, not the trial’s documented original design. The registry record does not report the study’s sample-size justification. Planning calculations are not observed power and do not show that a treatment effect was present. In this case, their interpretation must also account for the stated absence of completed primary analyses and the lack of a reported primary effect estimate.
Where a calculation is described as recalculated, it represents a simple unadjusted re-calculation from posted summary statistics, not a replacement for the sponsor’s own analysis. If the record identifies a discrepancy, the sponsor’s own analysis takes precedence. The registry contains no completed primary analysis to serve as an efficacy result, and no recalculation can recover unreported outcome measurements or resolve the missing analysis plan. Statistical output should therefore be interpreted only within the limits of what the record actually reports.
What can the design establish?
Random assignment and masking are features intended to strengthen a comparison, but they cannot compensate for absent outcome results. A randomized design supports causal interpretation when the study is conducted and analyzed appropriately; that general principle does not create an effect estimate when the primary analysis was not completed. Here, the record documents the design but does not permit a conclusion about the primary treatment contrast.
Why does low enrollment matter?
In general, fewer observations tend to leave estimates less precise, although precision also depends on outcome variability and the analysis. The record states that enrollment was low and that the study was terminated for that reason. It does not report the planned enrollment target, the reason for that target, or the statistical power considered during study planning. Thus, neither the size of the intended evidence base nor the precision that would have been expected can be established from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study assesses multiple outcomes, time points, or comparisons. In general, testing many hypotheses can increase the chance of a seemingly notable finding unless the analysis plan addresses that issue. The registry lists two outcome measures, and the primary-outcome title refers to hepatic steatosis and other factors. However, the specific measures, any hierarchy among them, and any multiplicity adjustment are not reported in the registry record. No primary analyses were completed, so there are no reported primary tests to interpret.
The registry record does not describe missing-data procedures, the amount of missing outcome data, or the analysis population. It does not report whether the primary comparison was planned as intention-to-treat, per-protocol, or another approach. These distinctions matter in general because exclusions and missing measurements can affect the groups being compared and the interpretation of an estimate. They cannot be resolved from the enrollment and adverse-event summaries alone.
Termination for low enrollment is stated as the reason the study ended, but the record does not describe interim analyses, stopping boundaries, or a statistical stopping rule. Those details should not be inferred from termination status. The primary analyses were never completed, and the registry lists zero analyses. Consequently, there is no reported multiplicity strategy, missing-data analysis, or analysis-population definition to assess.
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-acid Ethyl Esters (Lovaza) | 1 | 3 | 33.3% |
| Placebo | 0 | 6 | 0.0% |
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 |
|---|---|
| Omega-3-acid Ethyl Esters (Lovaza) | 2 of 3 |
| Placebo | 0 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Omega-3-acid Ethyl Esters (Lovaza) | Placebo |
|---|---|---|---|
| Herpes zoster | Infections and infestations | 1 of 3 | 0 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Omega-3-acid Ethyl Esters (Lovaza) | Placebo |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 2 of 3 | 0 of 6 |
Serious events with the highest arm-level rate: herpes zoster (33.3%).
The serious adverse-event figures are reported separately for each at-risk group. In the Lovaza group, 3 participants were at risk and 1 was affected by a serious adverse event. In the placebo group, 6 were at risk and 0 were affected. The other-adverse-event figures list 3 at risk and 2 affected in the Lovaza group, and 6 at risk and 0 affected in the placebo group. These are descriptive counts, not a complete comparative safety analysis.
The registry also lists herpes zoster as a top serious adverse-event term at 33.3%. The record does not provide enough detail in that listing to establish further event-level context. Death figures are not reported in the registry record. The counts should not be combined, converted into additional rates, or treated as proof of a treatment-related cause. In general, sparse safety data can be highly uncertain, and these figures do not establish that an event was caused by the assigned intervention. The record does not report a statistical comparison of adverse events.
12. What the Result Does, and Does Not, Mean
The trial record identifies a clinically focused question: whether omega-3-acid ethyl esters, given with dietary counseling, affect hepatic steatosis and related factors over 24 weeks compared with placebo and the same counseling. It also describes MRI assessment as a pilot objective. These details indicate what the study set out to investigate; they are not evidence that a benefit or harm was observed for the primary outcome.
The primary analyses were never completed after the study was terminated due to low enrollment. As a result, the registry record does not report a primary outcome estimate, a measure of its precision, or a completed comparison between the assigned groups. It cannot establish that the intervention did or did not change hepatic steatosis. It also cannot establish equivalence, because equivalence requires an appropriately defined comparison and analysis rather than a missing result.
The adverse-event counts provide limited descriptive information, but they do not answer the efficacy question. Nor do they support a robust conclusion about relative safety. The record’s lack of detail about the primary endpoint, analysis plan, missing data, and analysis populations further limits interpretation. The sample-size planning assumptions do not supply an efficacy result or demonstrate observed power.
In general, a trial can be informative through a precise estimate, an imprecise estimate, or a clearly documented feasibility experience. This record most directly documents the design and the difficulty of completing the study because of low enrollment. The results available in the registry do not quantify the treatment effect. Conclusions should therefore remain limited to the study’s registered question, its termination, and the descriptive safety information recorded.
13. Why This Trial Matters Statistically
This trial illustrates why a registered study question and a completed statistical result are different things. The record gives a randomized, quadruple-masked, parallel design and identifies the intended comparison, yet its primary-outcome description states that analyses were never completed. Without an outcome estimate and its uncertainty, the central clinical question remains unanswered in the registry record.
The study also highlights the value of precise endpoint definitions. “Hepatic steatosis and other factors” describes a broad topic rather than one clearly specified statistical outcome. Although MRI is identified as a way to assess hepatic steatosis, the record does not give the primary endpoint’s unit, parameter, or detailed measurement definition. Those omissions prevent a reader from determining what single effect would have been estimated or how precisely it could be interpreted.
Low enrollment is not merely a design detail: the record explicitly connects it to termination and the absence of primary analyses. The registry does not report the original sample-size justification, so the study’s intended precision cannot be assessed. The adverse-event counts also show why small descriptive summaries should not be mistaken for comprehensive comparative safety evidence. Overall, the record is useful for understanding the planned question and the limits of the available results, rather than for estimating efficacy.
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 is stated directly in the registry record: the study was terminated due to low enrollment, and primary analyses were never completed. There is consequently no reported primary efficacy estimate or uncertainty interval. The listed enrollment is 12, but the record does not provide the planned enrollment target or a sample-size justification.
The primary outcome is broad and lacks a reported unit, parameter, and detailed measurement description. Although the study summary describes MRI as a pilot assessment for quantifying hepatic steatosis, the registry does not report a completed MRI comparison. It also does not explain how the primary outcome’s reference to hepatic steatosis and other factors was operationalized.
Additional design and analysis details are not reported in the registry record, including eligibility criteria beyond the NASH context, the randomization procedure, the roles covered by quadruple masking, the statistical analysis plan, missing-data handling, and analysis populations. The adverse-event information is limited to the recorded at-risk and affected counts and the listed serious-event term; death figures are not reported in the registry record. These limitations leave the available evidence descriptive and incomplete, rather than suitable for estimating the primary treatment effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH) — NCT00845845.
- Registry record last updated 2013-07-24; status last verified 2013-06.
- Results first posted 2013-07-24.
- 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
NCT00845845 is a phase 2 randomized, quadruple-masked, parallel study sponsored by University of Illinois Chicago. It compared daily omega-3-acid ethyl esters (Lovaza) plus dietary counseling with daily placebo plus dietary counseling for 24 weeks. The listed enrollment is 12, and MRI assessment of hepatic steatosis is identified as a pilot objective and secondary outcome.
The record lists the study as terminated. It states that termination on October 12, 2010 was due to low enrollment and that primary analyses were never completed. The registry therefore reports no completed primary efficacy comparison. Adverse-event figures are descriptive, with the limitations described in the record; death figures are not reported in the registry record.