Clinical trial NCT01149538: Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Official title: Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Partial Fetal Alcohol Syndrome
Alcohol Related Neurodevelopmental Disorder
Prenatal Alcohol Exposure
Keywords: FASD
FAS
Alcohol
Prenatal Alcohol
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Side Effects of Choline Bitartrate
timeFrame: Baseline, 6 months, & 9 months
measure: Mullen Scales of Early Learning - Early Learning Composite
timeFrame: Baseline and 9 months
Secondary outcomes:
measure: Elicited Imitation Task Memory
timeFrame: Baseline, 6 months, and 9 months
measure: Evoked Response Potentials Microvolts
timeFrame: Baseline, 6 months, and 9 months
measure: Evoked Response Potential - Negative Component Latency
timeFrame: Baseline, 6 months, and 9 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jeffrey R Wozniak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Michael Georgieff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith SM, Virdee MS, Eckerle JK, Sandness KE, Georgieff MK, Boys CJ, Zeisel SH, Wozniak JR. Polymorphisms in SLC44A1 are associated with cognitive improvement in children diagnosed with fetal alcohol spectrum disorder: an exploratory study of oral choline supplementation. Am J Clin Nutr. 2021 Aug 2;114(2):617-627. doi: 10.1093/ajcn/nqab081.
citation: Wozniak JR, Fink BA, Fuglestad AJ, Eckerle JK, Boys CJ, Sandness KE, Radke JP, Miller NC, Lindgren C, Brearley AM, Zeisel SH, Georgieff MK. Four-year follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder. J Neurodev Disord. 2020 Mar 12;12(1):9. doi: 10.1186/s11689-020-09312-7.
citation: Wozniak JR, Fuglestad AJ, Eckerle JK, Fink BA, Hoecker HL, Boys CJ, Radke JP, Kroupina MG, Miller NC, Brearley AM, Zeisel SH, Georgieff MK. Choline supplementation in children with fetal alcohol spectrum disorders: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1113-25. doi: 10.3945/ajcn.114.099168. Epub 2015 Oct 7.