Clinical trial NCT02735473: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Official title: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-04-12
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
timeFrame: Change from baseline to 6 months in percentage correct
measure: Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months
timeFrame: Change from baseline to 9 months
Secondary outcomes:
measure: Stanford-Binet Intelligence Scales: 9 Months
timeFrame: Change from baseline to 9 months in IQ points
measure: Minnesota Executive Function Scale: 6 Months
timeFrame: Change from baseline to 6 months
measure: Minnesota Executive Function Scale: 9 Months
timeFrame: Change from baseline to 9 months in t-score points
measure: NIH Toolbox Flanker Task: 9 Months
timeFrame: Change from baseline to 9 months in fully-corrected t-score points
measure: NIH Toolbox Flanker Task: 6 Months
timeFrame: Change from baseline to 6 months
measure: Child Behavior Checklist: 6 Months
timeFrame: Change from baseline to 6 months
measure: Child Behavior Checklist: 9 Months
timeFrame: Change from baseline to 9 months in t-score points
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jeffrey R Wozniak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: