Evidence map›Paper›PMID 39956364›Full record

Trial reportThe American journal of clinical nutrition2025

Choline enhances elicited imitation memory performance in preschool children with prenatal alcohol exposure: a cumulative report of 3 randomized controlled trials.

Jeffrey R Wozniak, Judith K Eckerle, Blake A Gimbel, Abigail M Ernst, Mary E Anthony, Kent A Tuominen, Erik de Water, Steven H Zeisel, Michael K Georgieff

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of clinical nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01149538 phase1 / phase2completednot on this map

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

TypeinterventionalSponsorUniversity of MinnesotaRan2010 to 2014Enrolled60ConditionsFetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental DisorderArmsCholine bitartrate, Placebo for choline bitartrate
NCT02735473 phase2completednot on this map

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

TypeinterventionalSponsorUniversity of MinnesotaRan2016 to 2021Enrolled46ConditionsFetal Alcohol Spectrum DisordersArmsCholine bitartrate, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jeffrey R WozniakDepartment of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, United States. Electronic address: jwozniak@umn.edu.
Judith K EckerleDepartment of Pediatrics, University of Minnesota, Minneapolis, MN, United States.
Blake A GimbelDepartment of Pediatric Psychology and Neuropsychology, Nationwide Children's Hospital, Columbus, OH, United States; Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, United States.
Abigail M ErnstDepartment of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, United States.
Mary E AnthonyDepartment of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, United States.
Kent A TuominenDepartment of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, United States.
Erik de WaterGreat Lakes Neurobehavioral Center, Eagan, MN, United States.
Steven H ZeiselUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Michael K GeorgieffDepartment of Pediatrics, University of Minnesota, Minneapolis, MN, United States.

Funding

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum DisordersR01AA024123 · NIAAA · UNIVERSITY OF MINNESOTA · PI GEORGIEFF, MICHAEL K., WOZNIAK, JEFFREY ROBERT · 2015 to 2025
$4.6M
Postnatal Choline Supplementation in Children with Prenatal Alcohol ExposureR33AA019580 · NIAAA · UNIVERSITY OF MINNESOTA · PI WOZNIAK, JEFFREY ROBERT · 2011 to 2013
$647k
Postnatal Choline Supplementation in Children with Prenatal Alcohol ExposureR21AA019580 · NIAAA · UNIVERSITY OF MINNESOTA · PI WOZNIAK, JEFFREY ROBERT · 2009 to 2010
$405k
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum DisordersR56AA024123 · NIAAA · UNIVERSITY OF MINNESOTA · PI GEORGIEFF, MICHAEL K., WOZNIAK, JEFFREY ROBERT · 2020 to 2020
$154k
NIAAA NIH HHS R01 AA024123NIAAA NIH HHS R21 AA019580NIAAA NIH HHS R33 AA019580NIAAA NIH HHS R56 AA024123
6 · The paper itself

Abstract

backgroundFetal alcohol spectrum disorders (FASDs) are associated with neurocognitive deficits for which there are no biological treatments. Choline supplementation may attenuate these deficits.

objectivesThis study was aimed to evaluate choline as a neurodevelopmental intervention for preschool-aged children with FASD.

methodsWe present combined data from 104 participants with FASD (aged 2.5-5.9 y) from 3 placebo randomized controlled trials (RCTs). Participants in RCT1 and RCT2 were randomly assigned to 9 mo choline (500 mg daily) or placebo. Participants in RCT3 were randomly assigned to 9 mo choline (19 mg/kg daily) or placebo. The primary outcome measure was an elicited imitation (EI) memory task.

resultsAdherence was high (78% doses received). Adverse effects were similar across groups except fishy body odor: choline group, 36%; placebo group, 8%. We observed a trend-level choline advantage; participants receiving choline performed 25% better on EI short-delay adjacent pairs (sequential memory) than those on placebo, with a steeper increase in scores between 6 and 9 mo (ŷ = -10.06; P = 0.03; 95% CI: -19.13, -0.99). No sex difference in response was seen, nor did we observe a dose-response relationship. Age-moderated response to choline between baseline and 9 mo (ŷ = 10.02; P = 0.01; 95% CI: 2.47, 17.57), with greater response in younger (≤4.2 y) than that in older (>4.2 y) participants. Overall, choline showed a beneficial effect on memory but no impact on executive functioning or intelligent quotient.

conclusionsThe results support choline as a neurodevelopmental intervention for improvement of memory in young children exposed to alcohol prenatally. Specifically, the use of choline bitartrate as a supplement in the range of 260-500 mg/d in children between 2.5 and 5.9 y of age is supported. Future studies are needed to further define appropriate dosage as well as optimal lengths and developmental windows for supplementation. This trial was registered at clinicaltrials.gov as NCT01149538 and NCT02735473.

Indexed as

CholineFetal Alcohol Spectrum DisordersImitative BehaviorMemoryPrenatal Exposure Delayed EffectsChild, PreschoolDietary SupplementsFemaleHumansMalePregnancyCholinealcohol-related neurodevelopmental disorderchildrencholinecognitionfetal alcohol spectrum disordersfetal alcohol syndromememorypartial fetal alcohol syndromerandomized controlled trial

Identifiers

PMID39956364
PMCPMC12002193

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.