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Completed

NCT Number: NCT01149538

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

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.

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Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol Related Neurodevelopmental Disorder Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Syndrome Fetal Diseases Partial Fetal Alcohol Syndrome Pregnancy Complications Prenatal Alcohol Exposure Substance-Related Disorders Urogenital Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

choline bitartrate

Drug

Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Placebo for choline bitartrate

Dietary Supplement

Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Evoked Response Potential - Negative Component Latency

    Time frame: Baseline, 6 months, and 9 months

    Evoked Response Potential - negative component latency data are included.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2010
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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