Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
NCT ID: NCT01149538
Last Updated: 2016-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2010-07-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Choline Bitartrate
Choline Bitartrate supplementation
Choline bitartrate
Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Placebo
Placebo for choline bitartrate supplementation
Placebo for choline bitartrate
Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
Interventions
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Choline bitartrate
Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Placebo for choline bitartrate
Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Years
5 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Jeffrey R Wozniak, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Michael Georgieff, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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Wozniak JR, Eckerle JK, Gimbel BA, Ernst AM, Anthony ME, Tuominen KA, de Water E, Zeisel SH, Georgieff MK. Choline enhances elicited imitation memory performance in preschool children with prenatal alcohol exposure: a cumulative report of 3 randomized controlled trials. Am J Clin Nutr. 2025 Apr;121(4):921-931. doi: 10.1016/j.ajcnut.2025.02.009. Epub 2025 Feb 14.
Gimbel BA, Anthony ME, Ernst AM, Roediger DJ, de Water E, Eckerle JK, Boys CJ, Radke JP, Mueller BA, Fuglestad AJ, Zeisel SH, Georgieff MK, Wozniak JR. Long-term follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder: corpus callosum white matter microstructure and neurocognitive outcomes. J Neurodev Disord. 2022 Dec 16;14(1):59. doi: 10.1186/s11689-022-09470-w.
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.
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.
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.
Other Identifiers
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0910M73517
Identifier Type: -
Identifier Source: org_study_id