Trial · NCT01576783
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
NCT01576783, Phase 4, Completed, Sarah Keim; results first posted 2019-05-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes. Trials, record NCT01576783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01576783
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
- NCT number
- NCT01576783
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 377 participants, actual
- Lead sponsor
- Sarah Keim
- Conditions
- Preterm Birth, Child Development
- Interventions
- Docosahexaenoic Acid + Arachidonic Acid (DHA+AA), Placebo
- First posted
- 2012-04-12
- Last updated
- 2021-06-29
- Results first posted
- 2019-05-24
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Erythrocyte Fatty Acid Levels | Baseline to 180 days post-randomization | This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc |
| Primary | Erythrocyte Fatty Acid Levels (Additional Data) | Baseline to 180 days post-randomization | This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc |
| Primary | Enrollment and Trial Completion | Baseline to 180 days post-randomization | The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc. |
| Primary | Adherence | Baseline to 180 days post-randomization | The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc |
| Secondary | (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form) | Baseline to 180 days post-randomization | Infant Behavior Questionnaire-Revised (IBQ-R; short form) was used to assess effortful control (12 items) and activity level (3 items). The IBQ-R measures early temperament-based inhibitory control,a key component of executive function as children mature. Scores range from 1 to 7, with higher scores indicating greater frequency of behaviors. IBQ-R scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the IBQ-R value at 180 days minus the IBQ-R value at baseline). |
| Secondary | (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III) | Baseline to 180 days post-randomization | Bayley Scales of Infant and Toddler Development, third edition, (Bayley-III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items,score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Bayley-III scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the Bayley-III value at 180 days minus the Bayley-III value at baseline). Secondary Outcome for 1st stage of project funded by Allen Foundation, Inc; Primary Outcome for 2nd stage of project funded by March of Dimes and Health Resources and Services Administration |
| Other | Brief Infant Sleep Questionnaire (BISQ) | Baseline to 180 days post-randomization | The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the BISQ value at 180 days minus the BISQ value at baseline). |
| Other | Body Composition | Baseline to 180 days post-randomization | Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds). These measurements were converted to z scores for corrected age based on Child Growth Standards from the World Health Organization. The z-score indicates the number of standard deviations away from the mean. A z score of 0 is equal to the mean of a reference population (children the same age and sex). Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population. |
| Other | Brief Infant Toddler Social Emotional Assessment (BITSEA) | 180 days post-randomization | BITSEA measures socioemotional development in toddlerhood. Scores were summed to provide competence (range: 0-22) and problem (range: 0-62) scores, respectively. The problem scale is further divided into subscales: externalizing (6 items; range: 0-12), internalizing (8 items; range: 0-16), and dysregulation (8 items; range: 0-16). Additionally, 14 items comprise a red flag scale (range: 0-28). Eight items from the competence and nine items from the problem subscales are indicative of behaviors often seen in children with ASD. Each of the 17 ASD items was dichotomized to illustrate the presence (1) (i.e., competence items absent, problem items present) or absence (0) (i.e., competence items present, problem items absent) of each ASD behavior. Items were then summed to derive an ASD score (range: 0-17). Higher competence scores represent better functioning, whereas higher problem (including the problem subscales), red flag, and ASD scores were indicative of poorer functioning. |
| Other | Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II) | 180 days post-randomization | The PDDST-II is a clinically derived, caregiver-completed screener to assist in differentiating an ASD diagnosis from other disorders in children with developmental concerns, including those born preterm. The PDDST-II comprised 14 yes/no items that indicate the presence (1) or absence (0) of developmental concerns. Items were summed (possible range: 0-14) and higher scores represented greater developmental concern. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Erythrocyte Fatty Acid Levels | Baseline to 180 days post-randomization | Rows titles are fatty acids with different C:D ratio where, C= Carbohydrate; D = Double bond; C:D is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples | nmol/mL | MEAN |
| PRIMARY | Erythrocyte Fatty Acid Levels (Additional Data) | Baseline to 180 days post-randomization | Rows titles are fatty acids with different C:D ratio where, C= Carbohydrate; D = Double bond; C:D is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples | ratio | MEAN |
| PRIMARY | Enrollment and Trial Completion | Baseline to 180 days post-randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Adherence | Baseline to 180 days post-randomization | average percentage of packets consumed | MEAN | |
| SECONDARY | (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form) | Baseline to 180 days post-randomization | units on a scale | MEAN | |
| SECONDARY | (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III) | Baseline to 180 days post-randomization | units on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Brief Infant Sleep Questionnaire (BISQ) | Baseline to 180 days post-randomization | hours | MEAN | |
| OTHER_PRE_SPECIFIED | Body Composition | Baseline to 180 days post-randomization | z scores | MEAN | |
| OTHER_PRE_SPECIFIED | Brief Infant Toddler Social Emotional Assessment (BITSEA) | 180 days post-randomization | The number analyzed for the competence and ASD scales differs from the overall number analyzed due to missing data on these two scales. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II) | 180 days post-randomization | units on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Erythrocyte Fatty Acid Levels | Docosahexaenoic Acid + Arachidonic Acid | Linoleic acid (18:2n-6) | -2.1 | Standard Deviation 5.2 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Placebo | Linoleic acid (18:2n-6) | 0.6 | Standard Deviation 4.4 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Docosahexaenoic Acid + Arachidonic Acid | Arachidonic acid (20:4n-6) | 2.0 | Standard Deviation 2.6 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Placebo | Arachidonic acid (20:4n-6) | -0.2 | Standard Deviation 1.1 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Docosahexaenoic Acid + Arachidonic Acid | Total n-6 | 0.2 | Standard Deviation 6.0 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Placebo | Total n-6 | 0.4 | Standard Deviation 5.0 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Docosahexaenoic Acid + Arachidonic Acid | α-linolenic acid (18:3n-3) | -0.1 | Standard Deviation 0.4 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Placebo | α-linolenic acid (18:3n-3) | 0.0 | Standard Deviation 0.3 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Docosahexaenoic Acid + Arachidonic Acid | Eicosapentaenoic acid (20:5n-3) | 0.0 | Standard Deviation 0.1 | nmol/mL |
| Erythrocyte Fatty Acid Levels | Placebo | Eicosapentaenoic acid (20:5n-3) | -0.1 | Standard Deviation 0.2 | nmol/mL |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Docosahexaenoic Acid + Arachidonic Acid | 189 | |
| Overall Study | STARTED | Placebo | 188 | |
| Overall Study | COMPLETED | Docosahexaenoic Acid + Arachidonic Acid | 169 | |
| Overall Study | COMPLETED | Placebo | 171 | |
| Overall Study | NOT COMPLETED | Docosahexaenoic Acid + Arachidonic Acid | 20 | |
| Overall Study | NOT COMPLETED | Placebo | 17 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ENT Symptoms | Ear and labyrinth disorders | Docosahexaenoic Acid + Arachidonic Acid | 29 | 189 | |
| other | ENT Symptoms | Ear and labyrinth disorders | Placebo | 33 | 188 | |
| other | Gastrointestinal Symptoms | Gastrointestinal disorders | Docosahexaenoic Acid + Arachidonic Acid | 69 | 189 | |
| other | Gastrointestinal Symptoms | Gastrointestinal disorders | Placebo | 63 | 188 | |
| other | Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Docosahexaenoic Acid + Arachidonic Acid | 23 | 189 | |
| other | Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Placebo | 22 | 188 | |
| other | Skin/Limb Symptoms | Skin and subcutaneous tissue disorders | Docosahexaenoic Acid + Arachidonic Acid | 12 | 189 | |
| other | Skin/Limb Symptoms | Skin and subcutaneous tissue disorders | Placebo | 18 | 188 | |
| other | Behavioral Symptoms | Social circumstances | Docosahexaenoic Acid + Arachidonic Acid | 22 | 189 | |
| other | Behavioral Symptoms | Social circumstances | Placebo | 19 | 188 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docosahexaenoic Acid + Arachidonic Acid | 0 | 189 |
| Total, all-cause mortality | Placebo | 0 | 188 |
| Total, other adverse events | Docosahexaenoic Acid + Arachidonic Acid | 127 | 189 |
| Total, other adverse events | Placebo | 129 | 188 |
| Total, serious adverse events | Docosahexaenoic Acid + Arachidonic Acid | 0 | 189 |
| Total, serious adverse events | Placebo | 0 | 188 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Docosahexaenoic Acid + Arachidonic Acid vs Placebo: Other Long-term Outcomes: Number of Participants With Behavior Difficulties | Trial comparisons |
| Docosahexaenoic Acid + Arachidonic Acid vs Placebo: deaths from any cause | Trial comparisons |
| Docosahexaenoic Acid + Arachidonic Acid vs Placebo: Other Long-term Outcomes: Number of Participants With Developmental Delay | Trial comparisons |
| Docosahexaenoic Acid + Arachidonic Acid vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01576783
GET https://conductscience.org/api/trials/v1/NCT01576783/results?page=2