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Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Primary Purpose

Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Choline bitartrate
Placebo for choline bitartrate
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders focused on measuring FASD, FAS, Alcohol, Prenatal Alcohol

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Choline Bitartrate

Placebo

Arm Description

Choline Bitartrate supplementation

Placebo for choline bitartrate supplementation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Evoked Response Potentials Microvolts
Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.
Evoked Response Potential - Negative Component Latency
Evoked Response Potential - negative component latency data are included.

Full Information

First Posted
June 21, 2010
Last Updated
October 26, 2016
Sponsor
University of Minnesota
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01149538
Brief Title
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Official Title
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Prenatal Alcohol Exposure
Keywords
FASD, FAS, Alcohol, Prenatal Alcohol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Choline Bitartrate
Arm Type
Experimental
Arm Description
Choline Bitartrate supplementation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for choline bitartrate supplementation
Intervention Type
Drug
Intervention Name(s)
Choline bitartrate
Intervention Description
Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo for choline bitartrate
Intervention Description
Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
Primary Outcome Measure Information:
Title
Side Effects of Choline Bitartrate
Description
Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Time Frame
Baseline, 6 months, & 9 months
Title
Mullen Scales of Early Learning - Early Learning Composite
Description
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.
Time Frame
Baseline and 9 months
Secondary Outcome Measure Information:
Title
Elicited Imitation Task Memory
Description
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.
Time Frame
Baseline, 6 months, and 9 months
Title
Evoked Response Potentials Microvolts
Description
Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.
Time Frame
Baseline, 6 months, and 9 months
Title
Evoked Response Potential - Negative Component Latency
Description
Evoked Response Potential - negative component latency data are included.
Time Frame
Baseline, 6 months, and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey R Wozniak, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Georgieff, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33876196
Citation
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.
Results Reference
derived
PubMed Identifier
32164522
Citation
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.
Results Reference
derived
PubMed Identifier
26447156
Citation
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.
Results Reference
derived

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Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

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