Evidence map›Paper›PMID 24176229›Full record

Trial reportNutrition research (New York, N.Y.)2013

Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability.

Jeffrey R Wozniak, Anita J Fuglestad, Judith K Eckerle, Maria G Kroupina, Neely C Miller, Christopher J Boys, Ann M Brearley, Birgit A Fink, Heather L Hoecker, Steven H Zeisel and 1 more

Open access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Nutrition research (New York, N.Y.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

11 authors at 3 institutions in 1 country.

Jeffrey R WozniakDepartment of Psychiatry, University of Minnesota, Minneapolis, MN 55454, USA. Electronic address: jwozniak@umn.edu.
Anita J Fuglestad
Judith K Eckerle
Maria G Kroupina
Neely C Miller
Christopher J Boys
Ann M Brearley
Birgit A Fink
Heather L Hoecker
Steven H Zeisel
Michael K Georgieff
University of Minnesota · USEmory University · USUniversity of North Carolina at Chapel Hill · US

Funding

UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ian Michael Carroll · 1999 to 2026
$31.6M
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
NIAAA NIH HHS 5R21AA019580NIAAA NIH HHS R21 AA019580NIAAA NIH HHS R33 AA019580NIAAA NIH HHS R33AA019580NIDDK NIH HHS P30 DK056350NIDDK NIH HHS P30DK056350
6 · The paper itself

Abstract

There are no biological treatments for fetal alcohol spectrum disorders (FASDs), lifelong conditions associated with physical anomalies, brain damage, and neurocognitive abnormalities. In preclinical studies, choline partially ameliorates memory and learning deficits from prenatal alcohol exposure. This phase I pilot study evaluated the feasibility, tolerability, and potential adverse effects of choline supplementation in children with FASD. We hypothesized that choline would be well tolerated with minimal adverse events. The study design was a double-blind, randomized, placebo-controlled trial. Participants included 20 children aged 2.5 to 4.9 years with prenatal alcohol exposure and FASD diagnoses. Participants were randomly assigned to 500 mg choline or placebo daily for 9 months (10 active, 10 placebo). Primary outcome measures included feasibility, tolerability, adverse effects, and serum choline levels. Seventeen participants completed the study. Compliance was 82% to 87%, as evidenced by parent-completed log sheets and dose counts. Periodic 24-hour dietary recalls showed no evidence of dietary confounding. Adverse events were minimal and were equivalent in the active and placebo arms with the exception of fishy body odor, which occurred only in the active group. There were no serious adverse events to research participants. This phase I pilot study demonstrates that choline supplementation at 500 mg/d for 9 months in children aged 2 to 5 years is feasible and has high tolerability. Further examination of the efficacy of choline supplementation in FASD is currently underway.

Indexed as

Dietary SupplementsPatient ComplianceAlcohol DrinkingChild, PreschoolCholineDouble-Blind MethodFemaleFetal Alcohol Spectrum DisordersHumansMalePilot ProjectsPregnancyPrenatal Exposure Delayed EffectsTreatment OutcomeCholineadequate intakeAIalcohol-related neurodevelopmental disorderARNDcentral nervous systemChildrenCholineClinical trialCNSFASFASDFetal alcohol (FAS, FASD)fetal alcohol spectrum disordersfetal alcohol syndromeTreatment

Identifiers

PMID24176229
PMCPMC3815698
OpenAlexW2165698928

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.