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| Name | Class |
|---|---|
| Cures Within Reach | OTHER |
| Marci and Bill Ingram Fund for Autism Spectrum Disorders Research | UNKNOWN |
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The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCPUFA Oil Supplement | Experimental | EPA + DHA + GLA + OA oil supplement |
|
| Canola Oil Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCPUFA oil supplement | Drug | 2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 | The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline. | Baseline to 90 days post randomization |
| Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA) | Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline. | Baseline to 90 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Fatty Acid | The secondary outcome measures in this trial involve an examination of change in fatty acids from the first study visit to the final study visit. | Baseline to 90 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Future Full-scale Multi-site Study | Feasibility of a future full-scale multi-site study is assessed by examining the number of children screened, the proportion of these children who screen positive for ASD, the number of children who agree to participate in the trial, the number of children who return for the second and third study visits, baseline differences in individual fatty acids between the intervention and comparison groups, and adherence to the assigned treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Keim, PhD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35644107 | Derived | Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Effects of Omega-3-6-9 fatty acid supplementation on behavior and sleep in preterm toddlers with autism symptomatology: Secondary analysis of a randomized clinical trial. Early Hum Dev. 2022 Jun;169:105588. doi: 10.1016/j.earlhumdev.2022.105588. Epub 2022 May 19. | |
| 29490101 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) + Gamma-Linolenic acid (GLA) + Oleic Acid (OA) LCPUFA oil supplement: 2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg |
| FG001 | Canola Oil Placebo | Canola Oil Placebo: 2.5mL per day for 90 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement | Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) + Gamma-Linolenic acid (GLA) + Oleic Acid (OA) LCPUFA oil supplement: 2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2 | The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization |
|
Baseline to 90 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCPUFA Oil Supplement | EPA + DHA + GLA + OA oil supplement LCPUFA oil supplement: 2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Symptoms | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Keim | Nationwide Children's Hospital | 614-722-3177 | Sarah.Keim@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Canola Oil Placebo | Other | 2.5mL per day for 90 days |
|
| Pre-baseline to 90 days post randomization |
| Keim SA, Gracious B, Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Sheppard KW, Husk J, Rhoda DA. omega-3 and omega-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers. J Nutr. 2018 Feb 1;148(2):227-235. doi: 10.1093/jn/nxx047. |
| 28941976 | Derived | Boone KM, Gracious B, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Omega-3 and -6 fatty acid supplementation and sensory processing in toddlers with ASD symptomology born preterm: A randomized controlled trial. Early Hum Dev. 2017 Dec;115:64-70. doi: 10.1016/j.earlhumdev.2017.09.015. Epub 2017 Sep 20. |
| Canola Oil Placebo |
Canola Oil Placebo: 2.5mL per day for 90 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Canola Oil Placebo | Canola Oil Placebo: 2.5mL per day for 90 days |
|
|
|
| Primary | Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA) | Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 90 days post randomization |
|
|
|
|
| Secondary | Fatty Acid | The secondary outcome measures in this trial involve an examination of change in fatty acids from the first study visit to the final study visit. | Rows titles are fatty acids with different C:D ratio where, "C" stands for Carbohydrate; "D" stands for 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. | Posted | Mean | Standard Deviation | nmol/mL | Baseline to 90 days post randomization |
|
|
|
|
| Other Pre-specified | Feasibility: Future Full-scale Multi-site Study | Feasibility of a future full-scale multi-site study is assessed by examining the number of children screened, the proportion of these children who screen positive for ASD, the number of children who agree to participate in the trial, the number of children who return for the second and third study visits, baseline differences in individual fatty acids between the intervention and comparison groups, and adherence to the assigned treatment. | Posted | Count of Participants | Participants | Pre-baseline to 90 days post randomization |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | Canola Oil Placebo | Canola Oil Placebo: 2.5mL per day for 90 days | 0 | 16 | 0 | 16 | 16 | 16 |
| Ear Nose Throat Symptoms | Ear and labyrinth disorders | Systematic Assessment |
|
| Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and Limb Symptoms | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Behavioral Symptoms | Psychiatric disorders | Systematic Assessment |
|
| Cold/Fever | Infections and infestations | Systematic Assessment | Multi-symptom illnesses reported by caregivers which typically included more than 1 body system and/or fever |
|
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| D000091642 | Urogenital Diseases |
| D001519 | Behavior |
| Dysregulation |
|
| Externalizing |
|
| Internalizing |
|
| Austism Spectrum Disorder |
|
| Red Flag |
|
| The reported p-value is for the comparison of the change in Problem scores between groups (LCPUFA vs. Placebo). | Mixed Models Analysis | 0.92 | Threshold for statistical significance (<0.05). | Other | Analyses compared the change in the BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes |
| The reported p-value is for the comparison of the change in Dysregulation scores between groups (LCPUFA vs. Placebo). | Mixed Models Analysis | 0.88 | Other | Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes. |
| The reported p-value is for the comparison of the change in Externalizing scores between groups (LCPUFA vs. Placebo). | Mixed Models Analysis | 0.23 | Other | Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes. |
| The reported p-value is for the comparison of the change in Internalizing scores between groups (LCPUFA vs. Placebo). | Mixed Models Analysis | 0.91 | Other | Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes. |
| The reported p-value is for the comparison of the change in Austism Spectrum Disorder scores between groups (LCPUFA vs. Placebo). | Mixed Models Analysis | 0.03 | Other | Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes. |
| The reported p-value is for the comparison of the change in Red Flag scores between groups (LCPUFA vs. Placebo). | Mixed Models Analysis | 0.07 | Other | Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes. |
| 14:0 |
|
| 16:0 |
|
| 16:1n-7 |
|
| 18:0 |
|
| 18:1n-9 |
|
| 18:1n-7 |
|
| 18:2n-6 |
|
| 18:3n-6 |
|
| 18:3n-3 |
|
| 18:4n-3 |
|
| 20:3n-6 |
|
| 20:4n-6 |
|
| 20:5n-3 |
|
| 22:5n-3 |
|
| 22:6n-3 |
|
| total omega-6 |
|
| total omega-3 |
|
The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (12:0 nmol/mL) between groups (LCPUFA vs. Placebo). |
| t-test, 2 sided |
| 0.47 |
P-values <0.05 were considered statistically significant. |
| Other |
Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (14:0 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.38 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:0 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.02 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:1n-7 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.16 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:0 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.02 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:1n-9 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.02 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:2n-6 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.21 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.34 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-3 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.24 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:4n-3 nmol/mL ) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.50 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.07 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:4n-6 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.10 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.001 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.71 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:6n-3 nmol/mL) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.001 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (Total Omega-6) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.10 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |
| The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (total omega-3) between groups (LCPUFA vs. Placebo). | t-test, 2 sided | 0.10 | P-values <0.05 were considered statistically significant. | Other | Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests. |