Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Fetal Alcohol Spectrum Disorders

Treatments: Drug: Placebo; Drug: Choline bitartrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02735473

PSYCH-2016-23989

R01AA024123 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Choline bitartrate

Experimental group

Description:

Powdered drink mix containing choline bitartrate 19 mg. per kg.

Treatment:

Drug: Choline bitartrate

Placebo

Placebo Comparator group

Description:

Powdered drink mix containing matching placebo

Treatment:

Drug: Placebo