Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
|ClinicalTrials.gov Identifier: NCT01149538|
Recruitment Status : Completed
First Posted : June 23, 2010
Results First Posted : August 11, 2016
Last Update Posted : December 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Partial Fetal Alcohol Syndrome Alcohol Related Neurodevelopmental Disorder Prenatal Alcohol Exposure||Drug: Choline bitartrate Dietary Supplement: Placebo for choline bitartrate||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Choline Bitartrate
Choline Bitartrate supplementation
Drug: Choline bitartrate
Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Placebo Comparator: Placebo
Placebo for choline bitartrate supplementation
Dietary Supplement: Placebo for choline bitartrate
Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
- Side Effects of Choline Bitartrate [ Time Frame: 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 [ Time Frame: 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.
- Elicited Imitation Task Memory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 6 months, and 9 months ]Evoked Response Potential - negative component latency data are included.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149538
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Jeffrey R Wozniak, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Michael Georgieff, M.D.||University of Minnesota - Clinical and Translational Science Institute|