Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

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.

Time frame: Baseline and 9 months

Population: Including those with partial completion (drop-outs and lost-to-followup).

Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.

Time frame: Baseline, 6 months, & 9 months

Population: Children with fetal alcohol spectrum disorders receiving either choline or placebo for 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.

Time frame: Baseline, 6 months, and 9 months

Population: Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16).

Evoked Response Potential - negative component latency data are included.

Time frame: Baseline, 6 months, and 9 months

Population: Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms)

Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.

Time frame: Baseline, 6 months, and 9 months

Population: Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms)