Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

July 30, 2014 updated by: Jennifer Thomas, San Diego State University
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite the known damaging effects of alcohol on the developing fetus and the presence of warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. The consequences include a range of physical, neurological, and behavioral effects referred to as fetal alcohol spectrum disorders (FASD). Unfortunately, there are currently no comprehensive treatments for individuals with FASD. This pilot study will examine whether a nutritional intervention could reduce the severity of cognitive deficits associated with prenatal alcohol exposure. Choline is an essential nutrient, necessary for brain and behavioral development. Animal studies have shown that prenatal or early postnatal choline supplementation can lead to long-lasting cognitive enhancement. Similarly, choline supplementation improves cognitive outcomes among rats exposed to alcohol during development, even when administered postnatally and after alcohol exposure has occurred. The present experiment translates these findings to a clinical population of individuals exposed to heavy prenatal alcohol exposure. Subjects will be randomly assigned to receive daily choline supplementation or placebo control for a period of 6 weeks (approximately 20 subjects per group). Performance on neuropsychological tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks. These data will provide important information regarding a potential nutritional intervention for fetal alcohol spectrum disorders.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Center for Behavioral Teratology, San Diego State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed histories of prenatal alcohol exposure (by review of medical, legal, or social service records or maternal report, if available; information about levels and timing of exposure will be inquired, but not necessary for inclusion)
  • English as primary language

Exclusion Criteria:

  • Significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation
  • History of neurological condition (e.g., epilepsy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choline
Liquid glycerophosphocholine (GPC) supplement
Dietary supplement: Choline
5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline
Placebo Comparator: Placebo
Liquid placebo supplement
Dietary supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)
Time Frame: Baseline and 6 weeks
Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Investigators

  • Principal Investigator: Jennifer D. Thomas, Ph.D., San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT-choline-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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