Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Phase 1

Completed

• Conditions: Partial Fetal Alcohol Syndrome; Alcohol Related Neurodevelopmental Disorder; Fetal Alcohol Syndrome; Prenatal Alcohol Exposure; Fetal Alcohol Spectrum Disorders
• Interventions: Dietary Supplement: Placebo for choline bitartrate; Drug: Choline bitartrate

• Registration Number: NCT01149538
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-23
• Study Start: 2010-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2016-02-29
• Results First Submitted QC: 2016-06-30
• Results First Posted: 2016-08-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Available parent or legal guardian capable of participating in informed consent process
• Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
• Evidence of cognitive deficit in at least one neurocognitive domain

Exclusion Criteria

• History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
• History of medical condition known to affect brain function
• History of other neurodevelopmental disorder (ex. autism, down syndrome)
• History of very low birthweight (<1500 grams)
• History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo for choline bitartrate	Placebo for choline bitartrate supplementation
Choline Bitartrate	Choline bitartrate	Choline Bitartrate supplementation

Primary Outcome Measures

Name	Time	Method
Side Effects of Choline Bitartrate	Baseline, 6 months, & 9 months	Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Mullen Scales of Early Learning - Early Learning Composite	Baseline and 9 months	The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.

Secondary Outcome Measures

Name	Time	Method
Elicited Imitation Task Memory	Baseline, 6 months, and 9 months	The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.
Evoked Response Potentials Microvolts	Baseline, 6 months, and 9 months	Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.
Evoked Response Potential - Negative Component Latency	Baseline, 6 months, and 9 months	Evoked Response Potential - negative component latency data are included.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States