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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA019580 | 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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The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline Bitartrate | Experimental | Choline Bitartrate supplementation |
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| Placebo | Placebo Comparator | Placebo for choline bitartrate supplementation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline bitartrate | Drug | Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix. |
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| Measure | Description | Time Frame |
|---|---|---|
| Side Effects of Choline Bitartrate | Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact. | Baseline, 6 months, & 9 months |
| Mullen Scales of Early Learning - Early Learning Composite | The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details. | Baseline and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Elicited Imitation Task Memory | The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5. |
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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 |
| Michael Georgieff, M.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. | |
| 36526961 | Derived | Gimbel BA, Anthony ME, Ernst AM, Roediger DJ, de Water E, Eckerle JK, Boys CJ, Radke JP, Mueller BA, Fuglestad AJ, Zeisel SH, Georgieff MK, Wozniak JR. Long-term follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder: corpus callosum white matter microstructure and neurocognitive outcomes. J Neurodev Disord. 2022 Dec 16;14(1):59. doi: 10.1186/s11689-022-09470-w. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Choline Bitartrate | Choline Bitartrate supplementation Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix. |
| FG001 | Placebo | Placebo for choline bitartrate supplementation Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo for choline bitartrate | Dietary Supplement | Placebo for choline bitartrate, administered daily in fruit-flavored drink mix. |
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| Baseline, 6 months, and 9 months |
| Evoked Response Potentials Microvolts | Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included. | Baseline, 6 months, and 9 months |
| Evoked Response Potential - Negative Component Latency | Evoked Response Potential - negative component latency data are included. | Baseline, 6 months, and 9 months |
| 33876196 | Derived | Smith SM, Virdee MS, Eckerle JK, Sandness KE, Georgieff MK, Boys CJ, Zeisel SH, Wozniak JR. Polymorphisms in SLC44A1 are associated with cognitive improvement in children diagnosed with fetal alcohol spectrum disorder: an exploratory study of oral choline supplementation. Am J Clin Nutr. 2021 Aug 2;114(2):617-627. doi: 10.1093/ajcn/nqab081. |
| 32164522 | Derived | Wozniak JR, Fink BA, Fuglestad AJ, Eckerle JK, Boys CJ, Sandness KE, Radke JP, Miller NC, Lindgren C, Brearley AM, Zeisel SH, Georgieff MK. Four-year follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder. J Neurodev Disord. 2020 Mar 12;12(1):9. doi: 10.1186/s11689-020-09312-7. |
| 26447156 | Derived | Wozniak JR, Fuglestad AJ, Eckerle JK, Fink BA, Hoecker HL, Boys CJ, Radke JP, Kroupina MG, Miller NC, Brearley AM, Zeisel SH, Georgieff MK. Choline supplementation in children with fetal alcohol spectrum disorders: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1113-25. doi: 10.3945/ajcn.114.099168. Epub 2015 Oct 7. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Choline Bitartrate | Choline Bitartrate supplementation Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix. |
| BG001 | Placebo | Placebo for choline bitartrate supplementation Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
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| 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 | Side Effects of Choline Bitartrate | Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact. | Children with fetal alcohol spectrum disorders receiving either choline or placebo for 9 months | Posted | Number | participants | Baseline, 6 months, & 9 months |
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| Primary | Mullen Scales of Early Learning - Early Learning Composite | The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details. | Including those with partial completion (drop-outs and lost-to-followup). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 months |
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| Secondary | Elicited Imitation Task Memory | The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5. | Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16). | Posted | Mean | Standard Error | Slope | Baseline, 6 months, and 9 months |
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| Secondary | Evoked Response Potentials Microvolts | Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included. | Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms) | Posted | Mean | Standard Deviation | Mircovolts | Baseline, 6 months, and 9 months |
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| Secondary | Evoked Response Potential - Negative Component Latency | Evoked Response Potential - negative component latency data are included. | Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms) | Posted | Mean | Standard Deviation | Milliseconds | Baseline, 6 months, and 9 months |
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Adverse events reported here represent events EVER reported over the 9-month duration of the study.
Adverse events by organ system (percentage EVER reporting symptoms within each organ system listed - over 9 months). Events were collected in categories listed below (some include multiple symptoms). Individual symptom data exists in detailed notes for each participant but is not available in tallied form (except as aggregated into categories).
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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 | Choline Bitartrate supplementation Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix. | 0 | 31 | 15 | 31 | ||
| EG001 | Placebo | Placebo for choline bitartrate supplementation Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix. | 0 | 29 | 13 | 29 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skip problems | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment | Rash, sweating, nail changes |
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| Ear | Ear and labyrinth disorders | MedDRA (10.1) | Systematic Assessment | Sore throat, congestion, eye watering, dry eyes |
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| Cardiovascular | Cardiac disorders | MedDRA (10.1) | Systematic Assessment | Heart racing, rhythm disturbance, swelling |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment | Shortness of breath, wheezing, cough |
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| Gastrointestinal | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment | upset stomach, salivary changes, appetite change, diarrhea, constipation |
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| Fishy Body Odor | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment | Fishy body odor (a common result of choline supplementation) |
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| Genitourinary | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment | changes in urination pattern, incontinence, color changes |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment | pain, joint swelling, weakness, cramps |
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| Neurologic | Nervous system disorders | MedDRA (10.1) | Systematic Assessment | seizures, coordination problems, worsening of mood/behavior |
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| Allergy | Immune system disorders | MedDRA (10.1) | Systematic Assessment | flushing, itching, changes in tolerance to heat or cold |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey R. Wozniak, Ph.D. | University of Minnesota | 612-273-9741 | jwozniak@umn.edu |
| 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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D002794 | Choline |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |
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| Male |
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| 9 months energy level problems |
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| Baseline pain |
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| 6 month pain |
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| 9 month pain |
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| Baseline skin problems |
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| 6 month skin problems |
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| 9 month skin problems |
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| Baseline Ear Nose Throat problems |
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| 6 month Ear Nose Throat problems |
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| 9 month Ear Nose Throat problems |
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| Baseline headaches/dizziness |
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| 6 month headaches/dizziness |
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| 9 month headaches/dizziness |
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| Baseline vision problems |
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| 6 month vision problems |
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| 9 month vision problems |
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| Baseline cardiovascular |
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| 6 month cardiovascular |
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| 9 month cardiovascular |
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| Baseline respiratory problems |
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| 6 month respiratory problems |
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| 9 month respiratory problems |
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| Baseline gastrointestinal problems |
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| 6 month gastrointestinal problems |
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| 9 month gastrointestinal problems |
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| Baseline genitourinary problems |
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| 6 month genitourinary problems |
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| 9 month genitourinary problems |
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| Baseline musculoskeletal problems |
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| 6 month musculoskeletal problems |
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| 9 month musculoskeletal problems |
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| 6 month neurologic/psychiatric problems |
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| 9 month neurologic/psychiatric problems |
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| Baseline neurologic/psychiatric problems |
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| Baseline allergic problems |
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| 6 month allergic problems |
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| 9 month allergic problems |
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