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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 controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.
This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. 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 in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 months choline bitartrate | Experimental | Over the 9-month study, participants will receive a total of 3 months of choline bitartrate (19 mg/kg) and a total of 6 months of placebo |
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| 6 months choline bitartrate | Experimental | Over the 9-month study, participants will receive a total of 6 months of choline bitartrate (19 mg/kg) and a total of 3 months of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline Bitartrate | Drug | Powdered drink mix for daily consumption |
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| Measure | Description | Time Frame |
|---|---|---|
| Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm) | Elicited Imitation short-delay memory measure (percent correct for recall) | Change from baseline to 9 months |
| Stanford-Binet Intelligence Test (SB-5) | Stanford Binet Intelligence Test - 5th Edition | Change from baseline to 9 months |
| Minnesota Executive Function Scale (MEFS) | Minnesota Executive Function Scale - Early Childhood Version | Change from baseline to 9 months |
| NIH Toolbox Flanker Test | NIH Toolbox Flanker Inhibitory and Control Test | Change from baseline to 9 months |
| NIH Toolbox Picture Sequence Memory Test | NIH Toolbox Picture Sequence Memory Test | Change from baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior Checklist (CBCL) | Child Behavior Checklist - Parent Report Version | Change from baseline to 9 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 |
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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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| 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 |