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Fetal Alcohol Spectrum DisordersPhase 1/2NCT01149538

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

A Phase 1/2 study testing Choline bitartrate in people with Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 5 years
What is being tested?
Choline bitartrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Jul 2010to Sep 2014
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Available parent or legal guardian capable of participating in informed consent process
  • Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
  • Evidence of cognitive deficit in at least one neurocognitive domain

Who cannot join

  • History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
  • History of medical condition known to affect brain function
  • History of other neurodevelopmental disorder (ex. autism, down syndrome)
  • History of very low birthweight (<1500 grams)
  • History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota

    Minneapolis, Minnesota, 55454

Other trials in United States

About this study

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.

Being tested
Choline bitartrate, Placebo for choline bitartrate
Keywords
FASD, FAS, Alcohol, Prenatal Alcohol
Medical subject headings
Fetal Alcohol Spectrum Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Choline bitartrateDrug

    Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

  • Placebo for choline bitartrateDietary supplement

    Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Study groups in NCT01149538
Study groupRoleWhat they receive
Choline BitartrateExperimentalCholine Bitartrate supplementation
Receives: Drug: Choline bitartrate
PlaceboPlacebo comparatorPlacebo for choline bitartrate supplementation
Receives: Dietary Supplement: Placebo for choline bitartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Side Effects of Choline Bitartrate

    Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.

    Measured: Baseline, 6 months, & 9 months

  2. Mullen Scales of Early Learning - Early Learning Composite

    The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.

    Measured: Baseline and 9 months

Secondary outcomes (3)

  1. Elicited Imitation Task Memory

    The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.

    Measured: Baseline, 6 months, and 9 months

  2. Evoked Response Potentials Microvolts

    Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.

    Measured: Baseline, 6 months, and 9 months

  3. Evoked Response Potential - Negative Component Latency

    Evoked Response Potential - negative component latency data are included.

    Measured: Baseline, 6 months, and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01149538
Sponsor's protocol ID
0910M73517
Other IDs
R21AA019580
Status last verified
Oct 2016
First submitted
21 Jun 2010
Last updated
19 Dec 2016
Data monitoring committee
Yes

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.

    PubMed 39956364

  • 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.

    PubMed 36526961

  • 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.

    PubMed 33876196

  • 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.

    PubMed 32164522

  • 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.

    PubMed 26447156

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Choline bitartrate in people with Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Side Effects of Choline Bitartrate (time frame: Baseline, 6 months, & 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01149538, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.

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