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The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.
Despite the known damaging effects of alcohol on the developing fetus and the presence of warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. The consequences include a range of physical, neurological, and behavioral effects referred to as fetal alcohol spectrum disorders (FASD). Unfortunately, there are currently no comprehensive treatments for individuals with FASD. This pilot study will examine whether a nutritional intervention could reduce the severity of cognitive deficits associated with prenatal alcohol exposure. Choline is an essential nutrient, necessary for brain and behavioral development. Animal studies have shown that prenatal or early postnatal choline supplementation can lead to long-lasting cognitive enhancement. Similarly, choline supplementation improves cognitive outcomes among rats exposed to alcohol during development, even when administered postnatally and after alcohol exposure has occurred. The present experiment translates these findings to a clinical population of individuals exposed to heavy prenatal alcohol exposure. Subjects will be randomly assigned to receive daily choline supplementation or placebo control for a period of 6 weeks (approximately 20 subjects per group). Performance on neuropsychological tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks. These data will provide important information regarding a potential nutritional intervention for fetal alcohol spectrum disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline | Experimental | Liquid glycerophosphocholine (GPC) supplement |
|
| Placebo | Placebo Comparator | Liquid placebo supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline | Dietary Supplement | 5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF) | Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer D. Thomas, Ph.D. | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Behavioral Teratology, San Diego State University | San Diego | California | 92120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27806977 | Derived | Nguyen TT, Risbud RD, Mattson SN, Chambers CD, Thomas JD. Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders. Am J Clin Nutr. 2016 Dec;104(6):1683-1692. doi: 10.3945/ajcn.116.142075. Epub 2016 Nov 2. |
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| placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water | Dietary Supplement |
|
| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| D011248 | Pregnancy Complications |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental 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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