What side effects are associated with this type of intervention?

Choline supplementation, as studied for Fetal Alcohol Spectrum Disorders (FASD), is generally well-tolerated. Common side effects may include gastrointestinal disturbances such as nausea, diarrhea, and stomach cramps. In some cases, individuals may experience a fishy body odor due to the metabolism of choline. It is important to consult with a healthcare provider to determine the appropriate dosage and monitor for any adverse effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Fetal Alcohol Spectrum Disorders (FASD) mentioned in the provided context. However, the trial on choline supplementation is being studied for its potential to enhance cognitive function by supporting neurodevelopment in children with FASD. This suggests that choline, a nutrient known to play a critical role in brain development, is being explored as a therapeutic option.

What other types of research exist?

Promising, novel alternatives to choline supplementation for Fetal Alcohol Spectrum Disorders (FASD) patients may include S-adenosyl methionine (SAMe), which has shown efficacy in alleviating cognitive deficits and risk factors associated with neurodevelopmental disorders. Additionally, gene therapy and pharmacologic treatments like trofinetide, which are being explored for conditions such as Rett syndrome, could potentially be adapted for FASD treatment.

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Choline Supplementation for Fetal Alcohol Spectrum Disorders (CHOLINE4 Trial)

Q: What is the mechanism of action of this treatment?

Choline supplementation is a promising treatment for Fetal Alcohol Spectrum Disorders (FASD) due to its role in supporting neurodevelopment and cognitive function. Choline contributes to the synthesis of phospholipids, essential for cell membranes, and serves as a precursor for the neurotransmitter acetylcholine, which is crucial for memory and learning. This mechanism is particularly important for FASD patients as it may help mitigate the neurodevelopmental deficits caused by prenatal alcohol exposure, potentially improving cognitive outcomes and overall brain health.

Phase 2

Recruiting

Led By Jeffrey R Wozniak, Ph.D.

Research Sponsored by Jeff Wozniak

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 2.5 years to 5 years old (<6 years of age) at enrollment

Be younger than 18 years old

Must not have

History of a neurological condition (e.g., epilepsy, traumatic brain injury)

History of a medical condition known to affect brain function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving choline, a nutrient found in foods like eggs and meat, can help improve brain function in young children with Fetal Alcohol Spectrum Disorders (FASD). These children have cognitive issues due to alcohol exposure before birth. Choline might help their brains work better, especially for memory and thinking skills.

Who is the study for?

This trial is for children aged between 2.5 and 5 years who have been exposed to alcohol before birth and have a guardian able to consent. It's not for kids with conditions affecting brain function, other neurodevelopmental disorders like autism or Down syndrome, epilepsy, traumatic brain injuries, or those born weighing less than 1500 grams.

What is being tested?

The study tests if choline bitartrate supplements can help with cognitive development in kids with Fetal Alcohol Spectrum Disorders. It compares the effects of taking the supplement for either three months or six months in a randomized and double-blind setup.

What are the potential side effects?

Choline supplementation may cause minor side effects such as fishy body odor, vomiting, sweating, digestive issues like diarrhea or constipation; however these are generally considered rare and mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 2.5 and 5 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of a neurological condition.

Select...

I have a medical condition that affects my brain function.

Select...

I was born weighing less than 1500 grams.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)

Minnesota Executive Function Scale (MEFS)

NIH Toolbox Flanker Test

+2 more

Secondary study objectives

Child Behavior Checklist (CBCL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 6 months choline bitartrateExperimental Treatment1 Intervention

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

Group II: 3 months choline bitartrateExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Choline Bitartrate

2016

Completed Phase 4

~150

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Choline supplementation is a promising treatment for Fetal Alcohol Spectrum Disorders (FASD) due to its role in supporting neurodevelopment and cognitive function. Choline contributes to the synthesis of phospholipids, essential for cell membranes, and serves as a precursor for the neurotransmitter acetylcholine, which is crucial for memory and learning. This mechanism is particularly important for FASD patients as it may help mitigate the neurodevelopmental deficits caused by prenatal alcohol exposure, potentially improving cognitive outcomes and overall brain health.

Neonatal choline supplementation ameliorates the effects of prenatal alcohol exposure on a discrimination learning task in rats.