Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study (CHOLINE4)

Jeff Wozniak

Status and phase: Active, not recruiting; Phase 2

Conditions: Fetal Alcohol Spectrum Disorders

Treatments: Drug: Choline Bitartrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05108974

UMN-1506M74642

R01AA024123 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 30 to 72 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 2.5 years to 5 years old (<6 years of age) at enrollment
• Prenatal alcohol exposure
• Available parent or legal guardian capable of giving informed consent for participation.

Exclusion criteria

• History of a neurological condition (ex. epilepsy, traumatic brain injury)
• History of a medical condition known to affect brain function
• Other neurodevelopmental disorder (ex. autism, Down syndrome)
• History of very low birthweight (<1500 grams)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups

3 months choline bitartrate

Experimental group

Description:

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:

Drug: Choline Bitartrate

6 months choline bitartrate

Experimental group

Description:

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

Treatment:

Drug: Choline Bitartrate