Fetal Alcohol Spectrum Disorders Clinical Trial
Official title:
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Verified date | October 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
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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