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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02735473
Other study ID # PSYCH-2016-23989
Secondary ID R01AA024123
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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