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Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

NCT01149538 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-12-19

Study results available
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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.

Conditions

  • Fetal Alcohol Spectrum Disorders
  • Fetal Alcohol Syndrome
  • Partial Fetal Alcohol Syndrome
  • Alcohol Related Neurodevelopmental Disorder
  • Prenatal Alcohol Exposure

Interventions

DRUG

Choline bitartrate

Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

DIETARY_SUPPLEMENT

Placebo for choline bitartrate

Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey R Wozniak, Ph.D. · University of Minnesota

  • Michael Georgieff, M.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01149538 on ClinicalTrials.gov