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Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

This study is currently recruiting participants.
Verified February 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01149538
First received: June 21, 2010
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Partial Fetal Alcohol Syndrome
Alcohol Related Neurodevelopmental Disorder
Prenatal Alcohol Exposure
 Drug: Choline bitartrate
Dietary Supplement: Placebo for choline bitartrate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Side Effects of Choline Bitartrate [ Time Frame: 14 days, 1, 2, 3, 4, 5, 6, 7, 8 and 9 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline, 6 months, and 9 months ] [ Designated as safety issue: No ]
    The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure.


Secondary Outcome Measures:
  • Elicited Imitation Task Memory [ Time Frame: Baseline, 6 months, and 9 months ] [ Designated as safety issue: No ]
    An Elicited Imtation paradigm will be used to measure memory in the participants (immediate, delayed, interleaved).

  • Evoked Response Potentials [ Time Frame: Baseline, 6 months, and 9 months ] [ Designated as safety issue: No ]
    Evoked response potentials will be measured for the memory task and a separate visually-evoked response task (a measure of processing speed).


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149538

Contacts
Contact: Birgit A Fink, B.A. 612-624-0142 fasd@umn.edu
Contact: Jeffrey R Wozniak, Ph.D. 612-273-9741 jwozniak@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Principal Investigator: Jeffrey R Wozniak, Ph.D.            
Principal Investigator: Michael Georgieff, M.D.            
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Jeffrey R Wozniak, Ph.D. University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Michael Georgieff, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01149538     History of Changes
Other Study ID Numbers: 0910M73517, R21AA019580
Study First Received: June 21, 2010
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
FASD
FAS
Alcohol
Prenatal Alcohol

Additional relevant MeSH terms:
Fetal Alcohol Syndrome
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Fetal Diseases
Substance-Related Disorders
Choline
Lipotropic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013