Clinical Trial: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

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.

Detailed Summary: 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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Stanford-Binet Intelligence Scales: 9 months [ Time Frame: Change from baseline to 9 months ]
    Stanford-Binet Intelligence Scales at 9 months
  • Minnesota Executive Function Scale: 6 months [ Time Frame: Change from baseline to 6 months ]
    Minnesota Executive Function Scale - Early Childhood Version at 6 months
  • Minnesota Executive Function Scale: 9 months [ Time Frame: Change from baseline to 9 months ]
    Minnesota Executive Function Scale - Early Childhood Version at 9 months
  • NIH Toolbox Flanker Task: 6 months [ Time Frame: Change from baseline to 6 months ]
    NIH Toolbox Flanker Inhibitory and Control Task at 6 months
  • NIH Toolbox Flanker Task: 9 months [ Time Frame: Change from baseline to 9 months ]
    NIH Toolbox Flanker Inhibitory and Control Task at 9 months
  • Child Behavior Checklist: 6 months [ Time Frame: Change from baseline to 6 months ]
    Child Behavior Checklist - parent report instrument at 6 months
  • Child Behavior Checklist: 9 months [ Time Frame: Change from baseline to 9 months ]
    Child Behavior Checklist - parent report instrument at 9 months


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: April 2, 2016
Date Started: June 2016
Date Completion: May 2020
Last Updated: March 13, 2017
Last Verified: March 2017