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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA024123 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.
This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline bitartrate | Experimental | Powdered drink mix containing choline bitartrate 19 mg. per kg. |
|
| Placebo | Placebo Comparator | Powdered drink mix containing matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline bitartrate | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months | Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct. | Change from baseline to 6 months in percentage correct |
| Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months | Elicited Imitation memory paradigm - short delay memory measure at 9 months | Change from baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stanford-Binet Intelligence Scales: 9 Months | Stanford-Binet Intelligence Scales at 9 months; scores are standardized scores (mean 100 points, standard deviation of 15 points) | Change from baseline to 9 months in IQ points |
| Minnesota Executive Function Scale: 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey R Wozniak, Ph.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39956364 | Derived | Wozniak JR, Eckerle JK, Gimbel BA, Ernst AM, Anthony ME, Tuominen KA, de Water E, Zeisel SH, Georgieff MK. Choline enhances elicited imitation memory performance in preschool children with prenatal alcohol exposure: a cumulative report of 3 randomized controlled trials. Am J Clin Nutr. 2025 Apr;121(4):921-931. doi: 10.1016/j.ajcnut.2025.02.009. Epub 2025 Feb 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Choline Bitartrate | Powdered drink mix containing choline bitartrate 19 mg. per kg. Choline bitartrate |
| FG001 | Placebo | Powdered drink mix containing matching placebo Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Choline Bitartrate | Powdered drink mix containing choline bitartrate 19 mg. per kg. Choline bitartrate |
| BG001 | Placebo | Powdered drink mix containing matching placebo Placebo |
| 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 | Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months | Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct. | Posted | Mean | Standard Deviation | change in percentage correct | Change from baseline to 6 months in percentage correct |
|
Adverse event data were collected of the 9 months of the study + 1 additional month post-study
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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 | Choline Bitartrate | Powdered drink mix containing choline bitartrate 19 mg. per kg. Choline bitartrate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fishy body odor | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey R Wozniak | University of Minnesota | 612-273-9741 | jwozniak@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2020 | Sep 30, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2020 | Sep 16, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002794 | Choline |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
Minnesota Executive Function Scale - Early Childhood Version at 6 months |
| Change from baseline to 6 months |
| Minnesota Executive Function Scale: 9 Months | Minnesota Executive Function Scale - Early Childhood Version at 9 months; scores are in t-scores (mean=50, standard deviation=10) | Change from baseline to 9 months in t-score points |
| NIH Toolbox Flanker Task: 9 Months | NIH Toolbox Flanker Inhibitory and Control Task at 9 months; scores are fully-corrected t-scores (mean=40, standard deviation=10) | Change from baseline to 9 months in fully-corrected t-score points |
| NIH Toolbox Flanker Task: 6 Months | NIH Toolbox Flanker Inhibitory and Control Task at 6 months | Change from baseline to 6 months |
| Child Behavior Checklist: 6 Months | Child Behavior Checklist - parent report instrument at 6 months | Change from baseline to 6 months |
| Child Behavior Checklist: 9 Months | Child Behavior Checklist - parent report instrument at 9 months; scores are t-scores (mean=50, standard deviation=10) | Change from baseline to 9 months in t-score points |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Primary | Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months | Elicited Imitation memory paradigm - short delay memory measure at 9 months | Posted | Mean | Standard Deviation | change in percentage correct | Change from baseline to 9 months |
|
|
|
| Secondary | Stanford-Binet Intelligence Scales: 9 Months | Stanford-Binet Intelligence Scales at 9 months; scores are standardized scores (mean 100 points, standard deviation of 15 points) | Posted | Mean | Standard Deviation | Percentage change in full-scale IQ point | Change from baseline to 9 months in IQ points |
|
|
|
| Secondary | Minnesota Executive Function Scale: 6 Months | Minnesota Executive Function Scale - Early Childhood Version at 6 months | This measure was not collected at the 6-month visit but was completed at the 9-month visit. | Posted | Change from baseline to 6 months |
|
|
| Secondary | Minnesota Executive Function Scale: 9 Months | Minnesota Executive Function Scale - Early Childhood Version at 9 months; scores are in t-scores (mean=50, standard deviation=10) | Posted | Mean | Standard Deviation | Percentage change in overall score | Change from baseline to 9 months in t-score points |
|
|
|
| Secondary | NIH Toolbox Flanker Task: 9 Months | NIH Toolbox Flanker Inhibitory and Control Task at 9 months; scores are fully-corrected t-scores (mean=40, standard deviation=10) | Posted | Mean | Standard Deviation | Percentage change in fully-corrected t-s | Change from baseline to 9 months in fully-corrected t-score points |
|
|
|
| Secondary | NIH Toolbox Flanker Task: 6 Months | NIH Toolbox Flanker Inhibitory and Control Task at 6 months | This measure was not collected at the 6-month visit. It was, however, collected at the 9-month visit. | Posted | Change from baseline to 6 months |
|
|
| Secondary | Child Behavior Checklist: 6 Months | Child Behavior Checklist - parent report instrument at 6 months | This measure was not collected at the 6-month visit. It was collected at the 9-month visit. | Posted | Change from baseline to 6 months |
|
|
| Secondary | Child Behavior Checklist: 9 Months | Child Behavior Checklist - parent report instrument at 9 months; scores are t-scores (mean=50, standard deviation=10) | Posted | Mean | Standard Deviation | Change from baseline in t-score points | Change from baseline to 9 months in t-score points |
|
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| 0 |
| 23 |
| 0 |
| 23 |
| 17 |
| 23 |
| EG001 | Placebo | Powdered drink mix containing matching placebo Placebo | 0 | 23 | 0 | 23 | 16 | 23 |
| Hyper/hypo-activity | General disorders | Non-systematic Assessment |
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| Mood Changed | Psychiatric disorders | Non-systematic Assessment |
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| Headaches | General disorders | Non-systematic Assessment |
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| Stomach ache | Gastrointestinal disorders | Non-systematic Assessment |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000588 |
| Amines |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |