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Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

NCT01911299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2014-08-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

Conditions

  • Fetal Alcohol Spectrum Disorders
  • Fetal Alcohol Syndrome
  • Partial Fetal Alcohol Syndrome
  • Alcohol-related Neurodevelopmental Disorder
  • Prenatal Alcohol Exposure

Interventions

DIETARY_SUPPLEMENT

Choline

5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline

DIETARY_SUPPLEMENT

placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water

Sponsors & Collaborators

  • San Diego State University

    lead OTHER

Principal Investigators

  • Jennifer D. Thomas, Ph.D. · San Diego State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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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 NCT01911299 on ClinicalTrials.gov