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 Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy (NCT04810546), a randomized na study. The primary outcome is Participant Retention.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04810546 |
| Phase | NA |
| Condition | Iron-deficiency, Pregnancy Anemia, Obesity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 23 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Illinois Chicago |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns obese pregnant women at risk of iron-deficiency anemia. The registry describes eligibility in relation to hemoglobin ranges that differ by trimester and by whether participants are Black or non-Black. The study began the intervention in early second trimester, at 15-20 weeks of gestation. Further eligibility details, including a complete account of participant characteristics, are not reported in the registry record.
Intervention
The intervention was a once-daily oral bovine lactoferrin supplement, listed as 250mg. The intervention description also says participants were instructed to take prenatal vitamin/mineral supplement gummies without iron and with omega-3 fatty acids before bed. The registry describes the lactoferrin capsule as taken one hour before the afternoon meal.
Comparator
The comparator was usual care. Its description specifies a commercially available prenatal vitamin/mineral supplement containing iron and omega-3 fatty acids, taken before bed. Full details of the regimen and any other differences between the arms are not reported in the registry record.
Primary question
The primary question was whether participants could be retained in the study through labor and delivery, with retention expressed as a percentage by study arm. The posted outcome values are 58.0% for the lactoferrin arm and 63.0% for usual care. The registry does not post an estimated between-arm effect, uncertainty interval, or statistical test for this outcome. The study also listed maternal and neonatal iron-related measures as secondary outcomes, but their numerical results are not reported in the registry record.
3. Trial Design
This was a randomized, parallel-group study with single masking. The registry classifies its phase as NA and lists the study as completed. It records enrollment of 23. The study was sponsored by the University of Illinois Chicago and was conducted from 2022-02-01, with primary completion on 2024-10-09.
The arms were oral bovine lactoferrin and usual care. The lactoferrin arm description specifies a 250mg capsule once daily, alongside prenatal vitamin/mineral supplement gummies without iron and with omega-3 fatty acids. The comparator description specifies a commercially available prenatal vitamin/mineral supplement with iron and omega-3 fatty acids. Both descriptions place the regimen in early second trimester, at 15-20 weeks of gestation. The study summary describes follow-up through the time of labor; the primary outcome timeframe is listed as 8 months.
The registry does not say which participants were masked, how masking was maintained, how the randomization sequence was generated, or how treatment assignment was concealed. It also does not report the intended allocation ratio or a full protocol description. Those omissions limit assessment of how the randomized comparison was implemented. The trial’s stated primary goal was feasibility and acceptability, with participant retention as the posted primary outcome. The record lists five secondary outcomes concerning C-reactive protein, cord blood ferritin and hemoglobin, and maternal ferritin and hemoglobin. Numerical results for these outcomes 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 | Jarrow Formulas Oral Bovine Lactoferrin Supplement | Usual Care |
|---|---|---|
| STARTED | 12 | 11 |
| COMPLETED | 7 | 7 |
| NOT COMPLETED | 5 | 4 |
Analysis population for the primary outcome, as defined in the registry: Number of women eligible and approached.
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 | Jarrow Formulas Oral Bovine Lactoferrin Supplement | Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 12 | 11 | 23 | |
| Age, Continuous | years | 28.1 (SD 5.45) | 27.1 (SD 5.12) | 27.6 (SD 5.19) |
| Sex: Female, Male: Female | Participants | 12 | 11 | 23 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 | 3 | 9 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 8 | 13 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 8 | 13 |
| Race (NIH/OMB): White | Participants | 4 | 2 | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Region of Enrollment: United States | Participants | 12 | 11 | 23 |
| Screening Hemoglobin g/dL12 | grams per deciliter | 12.18 (SD 0.58) | 12.2 (SD 0.44) | 12.19 (SD 0.51) |
6. Primary Endpoint
The registry lists the primary outcome as Participant Retention, measured over 8 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants retained |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is participant retention, expressed as the percentage of women retained by study arm through the end of the study, described as labor and delivery. Its listed timeframe is 8 months. Retention is a feasibility measure: it describes whether participants remain in a study through the planned follow-up, rather than measuring a direct change in iron status or a clinical event related to anemia.
The registry posts a retention value of 58.0% for the oral lactoferrin arm and 63.0% for usual care. These percentages are the endpoint values available in the outcome record. The record does not post the underlying retained-participant counts, a confidence interval, or a statistical test for comparing the arms. It also does not explain how withdrawal, loss to follow-up, or delivery before a scheduled assessment was handled in calculating retention. Those details are not reported in the registry record.
Retention can help assess whether a study regimen and follow-up approach are practicable, but it does not by itself establish acceptability in every relevant sense. For example, the registry does not post a separate acceptability measure such as participant feedback. Nor does retention alone answer whether iron-related measurements changed. Such measurements appear among the listed secondary outcomes, but their numerical results are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is retention through labor and delivery. Its reported values are 58.0% in the oral bovine lactoferrin arm and 63.0% in the usual-care arm. These are descriptive arm-specific percentages. The registry record does not report a between-arm estimate, confidence interval, or hypothesis test, so the precision of the apparent difference and the strength of evidence for an arm contrast cannot be assessed from the posted results.
The record lists 23 participants enrolled and gives arm entries of 12.0 and 11.0. Those figures describe the registry’s arm records; they should not be treated as retained-participant counts. The retention percentages are not accompanied by numerators, and the outcome entry does not explain the calculation details. It is therefore not possible to reconstruct the retention calculation or assess how missing follow-up was handled from the registry record.
The trial is identified as a feasibility study, and retention is relevant to whether follow-up through labor and delivery can be maintained. However, the posted retention values alone do not establish why participants were or were not retained. The record does not report reasons for withdrawal, adherence, participant feedback, or other measures that could clarify feasibility or acceptability. The description of the study’s goal also mentions exploring maternal and neonatal effects, but the listed secondary outcomes have no numerical results in the registry record.
No statistical analysis is listed for the primary outcome: the registry records zero analyses, and the outcome is flagged as lacking values or being not estimable for a two-arm comparison. Consequently, no inferential conclusion about differences between the randomized groups is supported by the posted primary-outcome entry. This is not evidence that the groups are equivalent; it means that a comparative estimate and its uncertainty are not available in the record.
Safety information is also descriptive. Serious adverse events are recorded as zero affected participants in each arm, and deaths are recorded as zero in each arm. Other adverse events are recorded separately. These observations describe what the registry reports, but the record does not provide event-specific serious adverse-event terms or an analysis attributing events to study assignment. The small enrolled study and missing comparative estimates mean that the outcome entries should be read as a limited feasibility record, not as a definitive assessment of clinical effects or safety.
9. Statistical Methods Explained
What does a retention percentage describe?
A retention percentage expresses the share of an arm that remains under study through a defined endpoint. In this trial, the endpoint is retention through labor and delivery, and the registry lists the timeframe as 8 months. The percentage is a descriptive summary. To understand exactly how it was calculated, readers would also need the number retained, the denominator used, and the rules for handling incomplete follow-up. Those calculation details are not reported in the registry record.
Retention is not the same as adherence. A participant may remain in follow-up while not taking the assigned regimen as instructed, or may stop a regimen but still contribute outcome information. Conversely, someone may discontinue follow-up for reasons that do not establish whether the regimen itself was acceptable. The registry does not report adherence results, withdrawal reasons, or a separate participant-acceptability measure. Thus the posted retention outcome addresses one aspect of feasibility, not all aspects.
How should the arm values be interpreted?
The reported values, 58.0% and 63.0%, describe retention separately in the lactoferrin and usual-care arms. A comparative analysis would ordinarily estimate how far apart the arm outcomes are and quantify uncertainty around that estimate. A confidence interval is a statistical range intended to show the precision of an estimated effect under the assumptions of the analysis; wider intervals indicate less precise estimates. No comparative estimate or confidence interval is posted for retention, so neither the size nor precision of an arm contrast can be evaluated from the registry results.
A statistical test, if reported, could assess how compatible the observed data are with a specified null hypothesis under its assumptions. The registry lists zero analyses and flags the outcome as missing or not estimable for a two-arm comparison. No test result or p-value is reported. The arm percentages therefore should not be treated as proof that one regimen has a higher retention rate, nor as proof that the rates are the same.
What role does randomization play?
Random assignment is intended to make treatment groups comparable on average at the time of assignment, including for factors that may not have been measured. It supports a causal comparison when the assigned groups are analyzed appropriately and follow-up and outcome measurement are handled transparently. Randomization does not remove uncertainty, prevent loss to follow-up, or guarantee that the realized groups are balanced in a small study. The registry identifies randomized allocation, but does not report the sequence-generation or allocation-concealment methods, nor the analysis population used.
Single masking indicates that masking was used, but the record does not identify who was masked or describe how it was maintained. Such details matter because knowledge of assignment can influence behavior, reporting, follow-up, or assessment. Without them, readers cannot judge the practical protection against bias.
What does the sample-size illustration mean?
The registry’s sample-size assumptions describe an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The illustrated effect is described as a stated fraction of the observed effect. This is a planning exercise, not the trial’s own design justification and not observed power. Numerical sample-size illustration results are not reported in the registry record, so no required participant count can be stated from those assumptions.
In general, planning calculations estimate how much information a future study might need under specified assumptions. They are sensitive to the effect size chosen, the analysis method, outcome variability, and the desired operating characteristics. Reusing an effect observed in a small feasibility study can be particularly uncertain. The record does not report a sample-size justification for the completed trial, and no planning illustration should be mistaken for a measure of how likely this study was to detect an effect.
Why can over-dispersion matter for counts?
In general, count outcomes can vary more than a simple statistical model assumes. This is called over-dispersion. If a model ignores that extra variability, its uncertainty estimates can be too small and its tests can appear more conclusive than warranted. This general issue is relevant when analyzing event counts, but the registry does not report the model used for any outcome or provide an analysis that can be evaluated for over-dispersion. The posted primary endpoint is a percentage, and the record does not give enough analysis detail to infer a model.
No results are marked as recalculated, and no sponsor-versus-recalculation discrepancy is reported. The posted primary values remain descriptive registry entries; they are not accompanied by enough information to independently reconstruct an unadjusted comparison. No statistical plan, covariate adjustment strategy, interim analysis plan, or model specification is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five secondary outcomes: percentage change in C-reactive protein between baseline and third trimester, cord ferritin, cord hemoglobin, percentage change in maternal ferritin, and percentage change in maternal hemoglobin. It also records eight outcome measures overall. Numerical results for the listed secondary outcomes are not reported in the registry record, and the analysis count is zero. The record therefore does not permit assessment of whether these outcomes were analyzed or how their results related to the primary feasibility question.
When a study evaluates multiple outcomes or performs multiple tests, the chance of obtaining at least one apparently notable result can increase. Statistical approaches can address multiplicity, but the registry does not report whether any adjustment or hierarchy was planned. The statistical plan, including any prespecified prioritization of secondary outcomes, is not reported in the registry record. No multiplicity correction should be assumed.
The record does not describe the analysis population, the handling of missing outcome data, or the retention denominator. It does not report whether outcomes were analyzed according to randomized assignment or under another population definition. Nor does it explain how missing measurements, withdrawals, or incomplete follow-up were treated. These details are important because the amount and pattern of missing data can affect both descriptive summaries and treatment comparisons.
The available primary outcome values are arm-specific percentages, but no comparative estimate or uncertainty interval accompanies them. With no reported analysis method, readers cannot determine whether any adjustment, imputation, or sensitivity analysis was used. These gaps limit interpretation; they do not establish that a particular method was or was not used outside the registry record.
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 |
|---|---|---|---|
| Jarrow Formulas Oral Bovine Lactoferrin Supplement | 0 | 12 | 0.0% |
| Usual Care | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Jarrow Formulas Oral Bovine Lactoferrin Supplement | 0 of 12 |
| Usual Care | 0 of 11 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Jarrow Formulas Oral Bovine Lactoferrin Supplement | 11 of 12 |
| Usual Care | 8 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Jarrow Formulas Oral Bovine Lactoferrin Supplement | Usual Care |
|---|---|---|---|
| Non-serious AE | Gastrointestinal disorders | 7 of 12 | 4 of 11 |
| Obstetrics ER visit non-Gastrointestinal | Pregnancy, puerperium and perinatal conditions | 4 of 12 | 4 of 11 |
The registry separates serious adverse events from other adverse events. For serious adverse events, it records zero affected participants among 12 at risk in the lactoferrin arm and zero among 11 at risk in the usual-care arm. It also records zero deaths in each arm. These are the posted counts, not estimates of comparative risk.
For other adverse events, the registry records 11 affected among 12 at risk in the lactoferrin arm and 8 affected among 11 at risk in the usual-care arm. These are not the serious-event counts. The registry does not list serious adverse-event terms, and it does not provide event-specific details for the other adverse events in the information. It also does not report a statistical comparison or an assessment of whether events were related to the assigned regimen.
A zero count in a study of this size does not establish that serious events cannot occur, and the counts alone do not determine whether safety differs between arms. Interpretation would require fuller information about the events collected, follow-up, definitions, and analysis. Those details are not reported in the registry record. The safety figures should therefore be read as descriptive counts during the study, not as a definitive safety evaluation.
12. What the Result Does, and Does Not, Mean
The registry records a completed randomized feasibility study of oral bovine lactoferrin compared with usual care in obese pregnant women at risk of iron-deficiency anemia. The posted primary outcome concerns retention through labor and delivery. Its values are 58.0% for lactoferrin and 63.0% for usual care. These figures describe the registered outcome by arm, but are not accompanied by the retained-participant counts or a formal comparison.
The results do not establish whether retention differed between the arms, because no comparative estimate, confidence interval, or statistical test is reported. They also do not establish equivalence. A missing comparison is not evidence of no difference; it leaves the magnitude and uncertainty of any contrast unresolved. The registry’s analysis count is zero, and it flags the primary outcome as lacking values or not being estimable for a two-arm comparison.
The record does not provide numerical results for the listed secondary outcomes concerning inflammatory and iron-related measures. As a result, the posted record cannot be used to describe changes in maternal or neonatal iron status or to assess an effect on those measurements. Although the study summary gives a biological rationale for testing lactoferrin, that rationale is not itself evidence of an outcome effect.
The findings also cannot establish broad acceptability, adherence, or safety. Retention is one feasibility measure, while adherence and participant feedback are not reported. Serious adverse-event and death counts are recorded as zero in both arms, but the study’s adverse-event information does not include a comparative analysis or sufficient detail for a definitive safety conclusion. The appropriate interpretation is limited to the descriptive information in the registry record; it should not be extended to treatment recommendations or claims about clinical benefit.
13. Why This Trial Matters Statistically
This trial raises a statistical question that is common in feasibility research: a randomized design can be used to compare approaches, while the principal goal is to understand whether study procedures and follow-up can be carried through. Retention is directly relevant to that goal, but its usefulness depends on clear reporting of its denominator, calculation, and uncertainty. The registry posts arm-specific percentages but not the underlying retained-participant counts or a comparative analysis.
That distinction matters because descriptive values and inferential estimates answer different questions. Percentages show the observed summaries recorded for each arm. An estimated contrast with a confidence interval would communicate both the direction of the comparison and how precisely it is estimated. Without those elements, the posted values cannot show whether the apparent separation is compatible with substantial uncertainty or supports a more precise conclusion.
The study also illustrates why feasibility and clinical outcomes should not be conflated. The registry lists maternal and neonatal iron-related secondary outcomes, but does not report their numerical results. Retention therefore cannot stand in for evidence about those biological outcomes. Similarly, recording no serious adverse events does not establish that uncommon harms are absent or that risks are alike between arms.
For future readers and researchers, transparent reporting of analysis populations, missing-data handling, event definitions, adherence, participant feedback, and prespecified analyses would make a feasibility record more informative. Those elements are not reported in the registry record. The current entry is useful for identifying the study question, randomized design, primary feasibility measure, and descriptive results, while its missing analysis details sharply limit what can be inferred.
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 primary outcome is reported only as arm-specific percentages. The registry does not give the retained-participant counts, the exact denominators used, or a confidence interval. Although arm entries and safety denominators are recorded, the registry does not state that those figures are the denominators used to calculate retention. The calculation cannot therefore be independently checked from the record.
No comparative analysis is posted for the primary outcome, and the record lists zero analyses. It does not report an analysis population, missing-data methods, or a sensitivity analysis. Reasons for withdrawal and the timing of loss to follow-up are also not reported. These omissions make it difficult to assess whether the retention percentages reflect comparable follow-up processes across arms.
Details of trial implementation are incomplete. The registry does not identify who was masked, describe the randomization procedure or allocation concealment, or provide a full account of the intervention and comparator regimens. The arm descriptions are truncated, so their complete instructions cannot be assessed. Adherence and participant-reported acceptability are not reported, despite the study’s feasibility focus.
The record lists five secondary outcomes, but does not post their numerical results or statistical methods. It does not report a multiplicity strategy, the trial’s sample-size justification, an interim analysis plan, or a prespecified statistical analysis plan. The sample-size assumptions are described as a planning illustration based on the observed effect, but numerical illustration results are not reported. Serious adverse events and deaths are recorded as zero in each arm, while event terms and a comparative safety analysis are absent. Together, these limitations make the registry record informative about the study’s design and selected descriptive entries, but insufficient for a full evaluation of its analyses or clinical outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy — NCT04810546.
- Registry record last updated 2026-02-17; status last verified 2024-11.
- Results first posted 2026-02-17.
- 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
NCT04810546 is a completed randomized, parallel, single-masked study sponsored by the University of Illinois Chicago. The registry lists phase NA and enrollment of 23. The study compared once-daily oral bovine lactoferrin, listed as 250mg, with usual care in obese pregnant women at risk of iron-deficiency anemia.
The primary outcome was participant retention through labor and delivery, with a listed timeframe of 8 months. The registry reports retention values of 58.0% for the lactoferrin arm and 63.0% for usual care. It does not report a comparative estimate or statistical test. Five secondary outcomes are listed, but their numerical results are not reported in the registry record. Serious adverse events and deaths are recorded as zero in each arm; other adverse-event counts are listed separately.
The registry records study start on 2022-02-01 and primary completion on 2024-10-09. Its missing analysis details, retained-participant counts, and secondary-outcome results limit interpretation to the posted descriptive information.