Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
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ClinicalTrials.gov Identifier: NCT01911299 |
Recruitment Status :
Completed
First Posted : July 30, 2013
Last Update Posted : August 1, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Partial Fetal Alcohol Syndrome Alcohol-related Neurodevelopmental Disorder Prenatal Alcohol Exposure | Dietary Supplement: Choline Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Choline
Liquid glycerophosphocholine (GPC) supplement
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Dietary Supplement: Choline
5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline |
Placebo Comparator: Placebo
Liquid placebo supplement
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Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water |
- Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention [ Time Frame: Baseline and 6 weeks ]
- Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF) [ Time Frame: Baseline and 6 weeks ]Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.

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Ages Eligible for Study: | 5 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed histories of prenatal alcohol exposure (by review of medical, legal, or social service records or maternal report, if available; information about levels and timing of exposure will be inquired, but not necessary for inclusion)
- English as primary language
Exclusion Criteria:
- Significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation
- History of neurological condition (e.g., epilepsy)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911299
United States, California | |
Center for Behavioral Teratology, San Diego State University | |
San Diego, California, United States, 92120 |
Principal Investigator: | Jennifer D. Thomas, Ph.D. | San Diego State University |
Responsible Party: | Jennifer Thomas, Associate Director - Center for Behavioral Teratology, San Diego State University, San Diego State University |
ClinicalTrials.gov Identifier: | NCT01911299 |
Other Study ID Numbers: |
CBT-choline-1 |
First Posted: | July 30, 2013 Key Record Dates |
Last Update Posted: | August 1, 2014 |
Last Verified: | July 2014 |
Choline Glycerophosphocholine Choline alphoscerate Fetal alcohol spectrum disorders Fetal alcohol syndrome Partial fetal alcohol syndrome Alcohol-related neurodevelopmental disorder |
Prenatal alcohol exposure Fetal Alcohol Effects Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders Central Nervous System Agents Therapeutic Uses |
Fetal Alcohol Spectrum Disorders Disease Syndrome Neurodevelopmental Disorders Pathologic Processes Mental Disorders Fetal Diseases Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |
Choline Glycerol Lipotropic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Lipid Regulating Agents Nootropic Agents Cryoprotective Agents Protective Agents Physiological Effects of Drugs |