Trial record 2 of 19 for:    fetal alcohol syndrome

Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

This study is currently recruiting participants.
Verified November 2013 by San Diego State University
Sponsor:
Information provided by (Responsible Party):
Jennifer Thomas, San Diego State University
ClinicalTrials.gov Identifier:
NCT01911299
First received: July 26, 2013
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Partial Fetal Alcohol Syndrome
Alcohol-related Neurodevelopmental Disorder
Prenatal Alcohol Exposure
Dietary Supplement: Choline
Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.


Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01911299

Contacts
Contact: Tanya T. Nguyen, M.S. (619) 352-0214 tanya.nguyen@mail.sdsu.edu
Contact: Jennifer D. Thomas, Ph.D. (619) 594-0681 thomas3@mail.sdsu.edu

Locations
United States, California
Center for Behavioral Teratology, San Diego State University Recruiting
San Diego, California, United States, 92120
Sponsors and Collaborators
San Diego State University
Investigators
Principal Investigator: Jennifer D. Thomas, Ph.D. San Diego State University
  More Information

No publications provided

Responsible Party: Jennifer Thomas, Associate Director - Center for Behavioral Teratology, San Diego State University, San Diego State University
ClinicalTrials.gov Identifier: NCT01911299     History of Changes
Other Study ID Numbers: CBT-choline-1
Study First Received: July 26, 2013
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
Fetal alcohol spectrum disorders
Fetal alcohol syndrome
Partial fetal alcohol syndrome
Alcohol-related neurodevelopmental disorder
Prenatal alcohol exposure
Fetal Alcohol Effects
Alcohol-Induced Disorders
Alcohol-Related Disorders
Choline
Glycerophosphocholine
Choline alphoscerate
Pregnancy Complications
Central Nervous System Agents
Therapeutic Uses

Additional relevant MeSH terms:
Fetal Alcohol Syndrome
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Pregnancy Complications
Substance-Related Disorders
Central Nervous System Agents
Choline
Glycerol
Therapeutic Uses
Pharmacologic Actions
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014