Evidence map›Paper›PMID 32164522›Full record

Trial reportJournal of neurodevelopmental disorders2020

Four-year follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder.

Jeffrey R Wozniak, Birgit A Fink, Anita J Fuglestad, Judith K Eckerle, Christopher J Boys, Kristin E Sandness, Joshua P Radke, Neely C Miller, Christopher Lindgren, Ann M Brearley and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurodevelopmental disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01149538 (Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure), which is not on this map. Cited by 79 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 3 pooled it
25.2field-weighted citation impact, top 1% of its field
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
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 3 syntheses or guidelines pooled it, 112 citations in OpenAlex.

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  9. Prenatal choline supplementation improves child sustained attention: A 7-year follow-up of a randomized controlled feeding trial.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2022
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19 more citing papers are in PubMed but not listed here.

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

12 authors at 4 institutions in 1 country.

Jeffrey R WozniakUniversity of Minnesota Twin Cities, Minneapolis, MN, USA. jwozniak@umn.edu.
Birgit A FinkUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Anita J FuglestadUniversity of North Florida, Jacksonville, FL, USA.
Judith K EckerleUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Christopher J BoysUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Kristin E SandnessUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Joshua P RadkeFagron Inc., St. Paul, MN, USA.
Neely C MillerUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Christopher LindgrenUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Ann M BrearleyUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Steven H ZeiselUniversity of North Carolina, Nutrition Research Institute, Kannapolis, NC, USA.
Michael K GeorgieffUniversity of Minnesota Twin Cities, Minneapolis, MN, USA.
Twin Cities Orthopedics · USUniversity of Minnesota · USDavid H. Murdock Research Institute · USUniversity of North Florida · US

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR002494 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, WEISDORF, DANIEL J · 2018 to 2022
$34.9M
UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Venkata Saroja Voruganti · 1999 to 2026
$31.6M
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
NCATS NIH HHS UL1 TR002494NCATS NIH HHS UL1TR002494NIAAA NIH HHS R01 AA024123NIAAA NIH HHS R01AA024123NIAAA NIH HHS R21 AA019580NIAAA NIH HHS R33 AA019580NIAAA NIH HHS R33AA019580NIDDK NIH HHS P30 DK056350NIH HHS P30DK056350
6 · The paper itself

Abstract

backgroundDespite the high prevalence of fetal alcohol spectrum disorder (FASD), there are few interventions targeting its core neurocognitive and behavioral deficits. FASD is often conceptualized as static and permanent, but interventions that capitalize on brain plasticity and critical developmental windows are emerging. We present a long-term follow-up study evaluating the neurodevelopmental effects of choline supplementation in children with FASD 4 years after an initial efficacy trial.

methodsThe initial study was a randomized, double-blind, placebo-controlled trial of choline vs. placebo in 2-5-year-olds with FASD. Participants include 31 children (16 placebo; 15 choline) seen 4 years after trial completion. The mean age at follow-up was 8.6 years. Diagnoses were 12.9% fetal alcohol syndrome (FAS), 41.9% partial FAS, and 45.1% alcohol-related neurodevelopmental disorder. The follow-up included measures of intelligence, memory, executive functioning, and behavior.

resultsChildren who received choline had higher non-verbal intelligence, higher visual-spatial skill, higher working memory ability, better verbal memory, and fewer behavioral symptoms of attention deficit hyperactivity disorder than the placebo group. No differences were seen for verbal intelligence, visual memory, or other executive functions.

conclusionsThese data support choline as a potential neurodevelopmental intervention for FASD and highlight the need for long-term follow-up to capture treatment effects on neurodevelopmental trajectories.

trial registrationClinicalTrials.Gov #NCT01149538; Registered: June 23, 2010; first enrollment July 2, 2010.

Indexed as

Child, PreschoolCholineCognitionDouble-Blind MethodFemaleFetal Alcohol Spectrum DisordersFollow-Up StudiesHumansIntelligenceMaleMemory, Short-TermNootropic AgentsPregnancyPrenatal Exposure Delayed EffectsCholineNootropic AgentsCholineCognitionFetal alcohol spectrum disordersLongitudinal studiesRandomized controlled trials

Identifiers

PMID32164522
PMCPMC7066854
OpenAlexW3011633279

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.