Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

University of Minnesota46 enrolled

Overview

This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). 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 vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Choline bitartrateDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ages 2 years to 5 years of age 2. Available parent or legal guardian capable of giving informed consent for participation. 3. Documented prenatal alcohol exposure (self-report, social service records, or adoption records). 4. Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005). Exclusion Criteria: 1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury) 2. Known history of a medical condition known to affect brain function. 3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome) 4. Known history of very low birthweight (\<1500 grams)

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months

Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.

Time frame: Change from baseline to 6 months in percentage correct

Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months

Elicited Imitation memory paradigm - short delay memory measure at 9 months

Time frame: Change from baseline to 9 months

Secondary Outcomes

Stanford-Binet Intelligence Scales: 9 Months

Stanford-Binet Intelligence Scales at 9 months; scores are standardized scores (mean 100 points, standard deviation of 15 points)

Time frame: Change from baseline to 9 months in IQ points

Minnesota Executive Function Scale: 6 Months

Minnesota Executive Function Scale - Early Childhood Version at 6 months

Time frame: Change from baseline to 6 months

Minnesota Executive Function Scale: 9 Months

Minnesota Executive Function Scale - Early Childhood Version at 9 months; scores are in t-scores (mean=50, standard deviation=10)

Time frame: Change from baseline to 9 months in t-score points

NIH Toolbox Flanker Task: 9 Months

NIH Toolbox Flanker Inhibitory and Control Task at 9 months; scores are fully-corrected t-scores (mean=40, standard deviation=10)

Time frame: Change from baseline to 9 months in fully-corrected t-score points

NIH Toolbox Flanker Task: 6 Months

Data from ClinicalTrials.gov

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