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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fetal Alcohol Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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3 months choline bitartrate

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

Group Type EXPERIMENTAL

Choline Bitartrate

Intervention Type DRUG

Powdered drink mix for daily consumption

6 months choline bitartrate

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 Type EXPERIMENTAL

Choline Bitartrate

Intervention Type DRUG

Powdered drink mix for daily consumption

Interventions

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Choline Bitartrate

Powdered drink mix for daily consumption

Intervention Type DRUG

Other Intervention Names

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choline bitartrate formulated in drink mix specifically for this study

Eligibility Criteria

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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)

Minimum Eligible Age

30 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No