NCT01149538

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 11, 2016

Completed
Last Updated

December 19, 2016

Status Verified

October 1, 2016

Enrollment Period

4.2 years

First QC Date

June 21, 2010

Results QC Date

February 29, 2016

Last Update Submit

October 26, 2016

Conditions

Fetal Alcohol Spectrum DisordersFetal Alcohol SyndromePartial Fetal Alcohol SyndromeAlcohol Related Neurodevelopmental DisorderPrenatal Alcohol Exposure

Keywords

FASDFASAlcoholPrenatal Alcohol

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 6 months, & 9 months

  • 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.

    Baseline and 9 months

Secondary Outcomes (3)

  • Elicited Imitation Task Memory

    Baseline, 6 months, and 9 months

  • Evoked Response Potentials Microvolts

    Baseline, 6 months, and 9 months

  • Evoked Response Potential - Negative Component Latency

    Baseline, 6 months, and 9 months

Study Arms (2)

Choline Bitartrate

EXPERIMENTAL

Choline Bitartrate supplementation

Drug: Choline bitartrate

Placebo

PLACEBO COMPARATOR

Placebo for choline bitartrate supplementation

Dietary Supplement: Placebo for choline bitartrate

Interventions

Choline bitartrateDRUG

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

Choline Bitartrate
Placebo for choline bitartrateDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (5)

  • 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.

    PMID: 39956364DERIVED

  • 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.

    PMID: 36526961DERIVED

  • 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.

    PMID: 33876196DERIVED

  • 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.

    PMID: 32164522DERIVED

  • 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.

    PMID: 26447156DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Choline

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Results Point of Contact

Title
Jeffrey R. Wozniak, Ph.D.
Organization
University of Minnesota
jwozniak@umn.edu
612-273-9741

Study Officials

  • Jeffrey R Wozniak, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Michael Georgieff, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 23, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 19, 2016

Results First Posted

August 11, 2016

Record last verified: 2016-10

Locations

US(1)