Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735473
• Other study ID #: PSYCH-2016-23989
• Secondary ID: R01AA024123
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: September 10, 2021

Study information

• Verified date: October 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Drug:
• Choline bitartrate

• Placebo

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 6 months in percentage correct
Primary	Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months	Elicited Imitation memory paradigm - short delay memory measure at 9 months	Change from baseline to 9 months
Secondary	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)	Change from baseline to 9 months in IQ points
Secondary	Minnesota Executive Function Scale: 6 Months	Minnesota Executive Function Scale - Early Childhood Version at 6 months	Change from baseline to 6 months
Secondary	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)	Change from baseline to 9 months in t-score points
Secondary	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)	Change from baseline to 9 months in fully-corrected t-score points
Secondary	NIH Toolbox Flanker Task: 6 Months	NIH Toolbox Flanker Inhibitory and Control Task at 6 months	Change from baseline to 6 months
Secondary	Child Behavior Checklist: 6 Months	Child Behavior Checklist - parent report instrument at 6 months	Change from baseline to 6 months
Secondary	Child Behavior Checklist: 9 Months	Child Behavior Checklist - parent report instrument at 9 months; scores are t-scores (mean=50, standard deviation=10)	Change from baseline to 9 months in t-score points