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Trial record 14 of 36 for:    fetal alcohol children

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT02735473
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Spectrum Disorders Drug: Choline bitartrate Drug: Placebo Phase 2

Detailed Description:
This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Actual Study Start Date : June 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Choline bitartrate
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Drug: Choline bitartrate
Placebo Comparator: Placebo
Powdered drink mix containing matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. Elicited Imitation memory task - Short delay memory measure: 6 months [ Time Frame: Change from baseline to 6 months ]
    Elicited Imitation memory paradigm - short delay memory measure at 6 months

  2. Elicited Imitation memory task - Short delay memory measure: 9 months [ Time Frame: Change from baseline to 9 months ]
    Elicited Imitation memory paradigm - short delay memory measure at 9 months


Secondary Outcome Measures :
  1. Stanford-Binet Intelligence Scales: 9 months [ Time Frame: Change from baseline to 9 months ]
    Stanford-Binet Intelligence Scales at 9 months

  2. Minnesota Executive Function Scale: 6 months [ Time Frame: Change from baseline to 6 months ]
    Minnesota Executive Function Scale - Early Childhood Version at 6 months

  3. Minnesota Executive Function Scale: 9 months [ Time Frame: Change from baseline to 9 months ]
    Minnesota Executive Function Scale - Early Childhood Version at 9 months

  4. NIH Toolbox Flanker Task: 6 months [ Time Frame: Change from baseline to 6 months ]
    NIH Toolbox Flanker Inhibitory and Control Task at 6 months

  5. NIH Toolbox Flanker Task: 9 months [ Time Frame: Change from baseline to 9 months ]
    NIH Toolbox Flanker Inhibitory and Control Task at 9 months

  6. Child Behavior Checklist: 6 months [ Time Frame: Change from baseline to 6 months ]
    Child Behavior Checklist - parent report instrument at 6 months

  7. Child Behavior Checklist: 9 months [ Time Frame: Change from baseline to 9 months ]
    Child Behavior Checklist - parent report instrument at 9 months



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 2 years to 5 years of age
  2. Available parent or legal guardian capable of giving informed consent for participation.
  3. Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
  4. Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005).

Exclusion Criteria:

  1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
  2. Known history of a medical condition known to affect brain function.
  3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
  4. Known history of very low birthweight (<1500 grams)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735473


Contacts
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Contact: Jeffrey R Wozniak, Ph.D. 612-273-9741 jwozniak@umn.edu
Contact: Michael K Georgieff, M.D. 612-626-2971 georg001@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Chris Lindgren, MPH    612-624-0142    fasd@umn.edu   
Contact: Jeff Wozniak, Ph.D.    612-273-9741 ext Wozniak    jwozniak@umn.edu   
Principal Investigator: Jeffrey R Wozniak, Ph.D.         
Principal Investigator: Michael Georgieff, M.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Jeffrey R Wozniak, Ph.D. University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02735473     History of Changes
Other Study ID Numbers: R01AA024123 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Disease
Pathologic Processes
Pregnancy Complications
Substance-Related Disorders
Chemically-Induced Disorders
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents