Phase 2
N=46
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Fetal Alcohol Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02735473 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months — 0.252; 0.183 change in percentage correct
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Choline bitartrate (Drug); Placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months |
0.252; 0.183 | — |
| PRIMARY Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months |
0.318; 0.668 | — |
| SECONDARY Stanford-Binet Intelligence Scales: 9 Months |
0.198; 0.008 | — |
| SECONDARY Minnesota Executive Function Scale: 6 Months |
— | — |
| SECONDARY Minnesota Executive Function Scale: 9 Months |
0.007; 0.017 | — |
| SECONDARY NIH Toolbox Flanker Task: 9 Months |
0.091; -0.169 | — |
| SECONDARY NIH Toolbox Flanker Task: 6 Months |
— | — |
| SECONDARY Child Behavior Checklist: 6 Months |
— | — |
| SECONDARY Child Behavior Checklist: 9 Months |
-1.9; -1.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ages 2 years to 5 years of age
- Available parent or legal guardian capable of giving informed consent for participation.
- Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
- 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
- Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
- Known history of a medical condition known to affect brain function.
- Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
- Known history of very low birthweight (<1500 grams)
Data sourced from ClinicalTrials.gov (NCT02735473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.