Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

October 26, 2016 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choline Bitartrate
Choline Bitartrate supplementation
Drug: Choline bitartrate
Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Placebo Comparator: Placebo
Placebo for choline bitartrate supplementation
Dietary supplement: Placebo for choline bitartrate
Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effects of Choline Bitartrate
Time Frame: Baseline, 6 months, & 9 months
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
Time Frame: Baseline and 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elicited Imitation Task Memory
Time Frame: Baseline, 6 months, and 9 months
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.
Baseline, 6 months, and 9 months
Evoked Response Potentials Microvolts
Time Frame: Baseline, 6 months, and 9 months
Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.
Baseline, 6 months, and 9 months
Evoked Response Potential - Negative Component Latency
Time Frame: Baseline, 6 months, and 9 months
Evoked Response Potential - negative component latency data are included.
Baseline, 6 months, and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jeffrey R Wozniak, Ph.D., University of Minnesota
  • Principal Investigator: Michael Georgieff, M.D., University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0910M73517
  • R21AA019580 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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