Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Jeff Wozniak
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
Study Overview
Brief Summary
This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.
Detailed Description
This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. 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 in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Months to 72 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 2.5 years to 5 years old (<6 years of age) at enrollment
- •Prenatal alcohol exposure
- •Available parent or legal guardian capable of giving informed consent for participation.
Exclusion Criteria
- •History of a neurological condition (ex. epilepsy, traumatic brain injury)
- •History of a medical condition known to affect brain function
- •Other neurodevelopmental disorder (ex. autism, Down syndrome)
- •History of very low birthweight (<1500 grams)
Arms & Interventions
3 months choline bitartrate
Over the 9-month study, participants will receive a total of 3 months of choline bitartrate (19 mg/kg) and a total of 6 months of placebo
Intervention: Choline Bitartrate (Drug)
6 months choline bitartrate
Over the 9-month study, participants will receive a total of 6 months of choline bitartrate (19 mg/kg) and a total of 3 months of placebo
Intervention: Choline Bitartrate (Drug)
Outcomes
Primary Outcomes
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
Time Frame: Change from baseline to 9 months
Elicited Imitation short-delay memory measure (percent correct for recall)
Stanford-Binet Intelligence Test (SB-5)
Time Frame: Change from baseline to 9 months
Stanford Binet Intelligence Test - 5th Edition
Minnesota Executive Function Scale (MEFS)
Time Frame: Change from baseline to 9 months
Minnesota Executive Function Scale - Early Childhood Version
NIH Toolbox Flanker Test
Time Frame: Change from baseline to 9 months
NIH Toolbox Flanker Inhibitory and Control Test
NIH Toolbox Picture Sequence Memory Test
Time Frame: Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
Secondary Outcomes
- Child Behavior Checklist (CBCL)(Change from baseline to 9 months)
Investigators
Jeff Wozniak
Professor
University of Minnesota