drugset / Trial / NCT01149538
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Phase 1/2
Completed
60 enrolled
University of Minnesota
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2010-07
- Primary completion
- 2014-09
- Completion
- 2014-09
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Choline | Other / unclassified | 500 mg | Oral |