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Published on: August 5, 2017
Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability
Jeffrey R Wozniak1, Anita J Fuglestad, Judith K Eckerle
1Department of Psychiatry, University of Minnesota, Minneapolis, MN 55454, USA.
Insights
Choline supplementation is safe and well-tolerated in children with fetal alcohol spectrum disorders (FASD). This pilot study found choline feasible for children with FASD, paving the way for efficacy trials.
Area of Science:
- Neuroscience
- Pediatrics
- Nutritional Science
Background:
- Fetal alcohol spectrum disorders (FASDs) present lifelong challenges with no current biological treatments.
- Prenatal alcohol exposure can lead to physical anomalies, brain damage, and neurocognitive deficits.
- Preclinical research suggests choline may mitigate memory and learning impairments from prenatal alcohol exposure.
Purpose of the Study:
- To assess the feasibility and tolerability of choline supplementation in children diagnosed with FASD.
- To evaluate potential adverse effects associated with choline supplementation in this pediatric population.
- To establish safe dosage and administration protocols for future efficacy studies.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 20 children aged 2.5 to 4.9 years with FASD.
- Participants received either 500 mg of choline or a placebo daily for 9 months.
- Feasibility, tolerability, adverse events, and serum choline levels were primary outcome measures.
Main Results:
- The study demonstrated high feasibility and tolerability, with 17 out of 20 participants completing the trial.
- Compliance rates ranged from 82% to 87%, indicating good adherence.
- Adverse events were minimal and similar between groups, with fishy body odor noted in the choline group; no serious adverse events occurred.
Conclusions:
- Choline supplementation at 500 mg/day for 9 months is feasible and well-tolerated in young children (2-5 years) with FASD.
- The findings support further investigation into the efficacy of choline for treating FASD.
- This pilot study provides a foundation for larger clinical trials examining choline's therapeutic potential in FASD.
Abstract:
There are no biological treatments for fetal alcohol spectrum disorders (FASDs), lifelong conditions associated with physical anomalies, brain damage, and neurocognitive abnormalities. In preclinical studies, choline partially ameliorates memory and learning deficits from prenatal alcohol exposure. This phase I pilot study evaluated the feasibility, tolerability, and potential adverse effects of choline supplementation in children with FASD. We hypothesized that choline would be well tolerated with minimal adverse events. The study design was a double-blind, randomized, placebo-controlled trial. Participants included 20 children aged 2.5 to 4.9 years with prenatal alcohol exposure and FASD diagnoses. Participants were randomly assigned to 500 mg choline or placebo daily for 9 months (10 active, 10 placebo). Primary outcome measures included feasibility, tolerability, adverse effects, and serum choline levels. Seventeen participants completed the study. Compliance was 82% to 87%, as evidenced by parent-completed log sheets and dose counts. Periodic 24-hour dietary recalls showed no evidence of dietary confounding. Adverse events were minimal and were equivalent in the active and placebo arms with the exception of fishy body odor, which occurred only in the active group. There were no serious adverse events to research participants. This phase I pilot study demonstrates that choline supplementation at 500 mg/d for 9 months in children aged 2 to 5 years is feasible and has high tolerability. Further examination of the efficacy of choline supplementation in FASD is currently underway.
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