Evidence map›Paper›PMID 29750367›Full record

Trial reportAlcoholism, clinical and experimental research2018

Efficacy of Maternal Choline Supplementation During Pregnancy in Mitigating Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Sandra W Jacobson, R Colin Carter, Christopher D Molteno, Mark E Stanton, Jane S Herbert, Nadine M Lindinger, Catherine E Lewis, Neil C Dodge, H Eugene Hoyme, Steven H Zeisel and 3 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alcoholism, clinical and experimental research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04694235 (Effect on Pregnancy Outcomes, Infant Growth and Development of an Egg Intervention During Pregnancy in Indonesia), which is not on this map. Cited by 100 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 5 pooled it
23.6field-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.

NCT04694235 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Effect on Pregnancy Outcomes, Infant Growth and Development of an Egg Intervention During Pregnancy in Indonesia

TypeinterventionalSponsorSEAMEO Regional Centre for Food and NutritionRan2021 to 2024Enrolled702ConditionsWeight Gain, Anemia, Iron Deficiency, Birth Weight, Birth LengthArmsEgg intervention
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 5 syntheses or guidelines pooled it, 148 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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40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 3 countries.

Sandra W JacobsonDepartment of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan.ORCID 0000-0002-9768-2671
R Colin CarterDivision of Pediatric Emergency Medicine, Morgan Stanley Children's Hospital of New York, New York, New York.ORCID 0000-0003-1554-6914
Christopher D MoltenoDepartment of Psychiatry and Mental Health, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.ORCID 0000-0001-6688-2614
Mark E StantonDepartment of Psychology, University of Delaware, Newark, Delaware.ORCID 0000-0003-3672-4484
Jane S HerbertDepartment of Psychology, University of Wollongong, New South Wales, Australia.ORCID 0000-0002-8762-4531
Nadine M LindingerDepartment of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.ORCID 0000-0003-4148-2643
Catherine E LewisDepartment of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.ORCID 0000-0001-5056-438X
Neil C DodgeDepartment of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan.ORCID 0000-0002-5666-3060
H Eugene HoymeDepartment of Pediatrics, Sanford School of Medicine, University of South Dakota, Sioux Falls, South Dakota.ORCID 0000-0002-1979-693X
Steven H ZeiselNutrition Research Institute, University of North Carolina at Chapel Hill, Kannapolis, North Carolina.ORCID 0000-0002-9282-161X
Ernesta M MeintjesDepartment of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-0781-3632
Christopher P DugganDivision of Gastroenterology, Hepatology and Nutrition, Center for Nutrition, Boston Children's Hospital/Harvard Medical School, Boston, Massachusetts.ORCID 0000-0001-8083-8193
Joseph L JacobsonDepartment of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan.ORCID 0000-0001-8271-280X
University of Cape Town · ZABoston Children's Hospital · USMorgan Stanley Children's Hospital · USUniversity of Arizona · USUniversity of Delaware · USUniversity of North Carolina at Chapel Hill · USUniversity of Wollongong · AUWayne State University · US

Funding

ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Elizabeth Austen Lawson, Takara Leah Stanley · 1994 to 2026
$31.6M
UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Venkata Saroja Voruganti · 1999 to 2026
$31.6M
Nutrigenetic analysis of choline status biomarkersR01DK115380 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ZEISEL, STEVEN H · 2018 to 2021
$2.8M
Neural Bases of Eyeblink Conditioning in FASDR01AA016781 · NIAAA · WAYNE STATE UNIVERSITY · PI JACOBSON, SANDRA W. · 2008 to 2012
$2.5M
Patient-oriented Research in Pediatric Diarrheal DiseasesK24DK104676 · NIDDK · BOSTON CHILDREN'S HOSPITAL · PI DUGGAN, CHRISTOPHER P · 2015 to 2019
$903k
The Role of Maternal Nutrition in the Teratogenesis of Alcohol in HumansK23AA020516 · NIAAA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI CARTER, ROBERT COLIN · 2011 to 2015
$891k
Exploratory Trial of Choline Supplementation for Fetal Alcohol SyndromeR21AA020332 · NIAAA · WAYNE STATE UNIVERSITY · PI JACOBSON, SANDRA W. · 2012 to 2013
$393k
NIAAA NIH HHS K23 AA020516NIAAA NIH HHS R01 AA016781NIAAA NIH HHS R21 AA020332NIDDK NIH HHS K24 DK104676NIDDK NIH HHS P30 DK040561NIDDK NIH HHS P30 DK056350NIDDK NIH HHS R01 DK115380
6 · The paper itself

Abstract

backgroundWe recently demonstrated the acceptability and feasibility of a randomized, double-blind choline supplementation intervention for heavy drinking women during pregnancy. In this study, we report our results relating to the efficacy of this intervention in mitigating adverse effects of prenatal alcohol exposure (PAE) on infant growth and cognitive function.

methodsSixty-nine Cape Coloured (mixed ancestry) heavy drinkers in Cape Town, South Africa, recruited in mid-pregnancy, were randomly assigned to receive a daily oral dose of either 2 g of choline or placebo from time of enrollment until delivery. Each dose consisted of an individually wrapped packet of powder that, when mixed with water, produced a sweet tasting grape-flavored drink. The primary outcome, eyeblink conditioning (EBC), was assessed at 6.5 months. Somatic growth was measured at birth, 6.5, and 12 months, recognition memory and processing speed on the Fagan Test of Infant Intelligence, at 6.5 and 12 months.

resultsInfants born to choline-treated mothers were more likely to meet criterion for conditioning on EBC than the placebo group. Moreover, within the choline arm, degree of maternal adherence to the supplementation protocol strongly predicted EBC performance. Both groups were small at birth, but choline-treated infants showed considerable catch-up growth in weight and head circumference at 6.5 and 12 months. At 12 months, the infants in the choline treatment arm had higher novelty preference scores, indicating better visual recognition memory.

conclusionsThis exploratory study is the first to provide evidence that a high dose of choline administered early in pregnancy can mitigate adverse effects of heavy PAE on EBC, postnatal growth, and cognition in human infants. These findings are consistent with studies of alcohol-exposed animals that have demonstrated beneficial effects of choline supplementation on classical conditioning, learning, and memory.

Indexed as

Dietary SupplementsAdultAlcohol DrinkingBirth WeightBlinkingCholineCognitionDouble-Blind MethodFemaleFetal Alcohol Spectrum DisordersHumansInfantMalePregnancyPrenatal Exposure Delayed EffectsSouth AfricaCholineCholine SupplementationEyeblink ConditioningFetal Alcohol Spectrum DisordersFetal Alcohol SyndromeGrowthPrenatal Alcohol Exposure

Identifiers

PMID29750367
PMCPMC6028282
OpenAlexW2800494954

What OpenQuestion holds

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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.