Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome; Partial Fetal Alcohol Syndrome; Alcohol Related Neurodevelopmental Disorder; Prenatal Alcohol Exposure	Drug: Choline bitartrate; Dietary Supplement: Placebo for choline bitartrate	Phase 1; Phase 2

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Study Start Date :	July 2010
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Choline Bitartrate; Choline Bitartrate supplementation	Drug: Choline bitartrate; Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Placebo Comparator: Placebo; Placebo for choline bitartrate supplementation	Dietary Supplement: Placebo for choline bitartrate; Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Side Effects of Choline Bitartrate [ Time Frame: Baseline, 6 months, & 9 months ]
   Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
2. Mullen Scales of Early Learning - Early Learning Composite [ Time Frame: Baseline and 9 months ]
   The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.

Secondary Outcome Measures :

1. Elicited Imitation Task Memory [ Time Frame: Baseline, 6 months, and 9 months ]
   The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.
2. Evoked Response Potentials Microvolts [ Time Frame: Baseline, 6 months, and 9 months ]
   Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.
3. Evoked Response Potential - Negative Component Latency [ Time Frame: Baseline, 6 months, and 9 months ]
   Evoked Response Potential - negative component latency data are included.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 5 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Available parent or legal guardian capable of participating in informed consent process
• Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
• Evidence of cognitive deficit in at least one neurocognitive domain

Exclusion Criteria:

• History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
• History of medical condition known to affect brain function
• History of other neurodevelopmental disorder (ex. autism, down syndrome)
• History of very low birthweight (<1500 grams)
• History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:	Jeffrey R Wozniak, Ph.D.	University of Minnesota - Clinical and Translational Science Institute
Principal Investigator:	Michael Georgieff, M.D.	University of Minnesota - Clinical and Translational Science Institute

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wozniak JR, Fuglestad AJ, Eckerle JK, Fink BA, Hoecker HL, Boys CJ, Radke JP, Kroupina MG, Miller NC, Brearley AM, Zeisel SH, Georgieff MK. Choline supplementation in children with fetal alcohol spectrum disorders: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1113-25. doi: 10.3945/ajcn.114.099168. Epub 2015 Oct 7.

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01149538 History of Changes
Other Study ID Numbers:	0910M73517; R21AA019580 ( U.S. NIH Grant/Contract )
First Posted:	June 23, 2010
Results First Posted:	August 11, 2016
Last Update Posted:	December 19, 2016
Last Verified:	October 2016

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

FASD; FAS; Alcohol; Prenatal Alcohol

Additional relevant MeSH terms:

Syndrome; Fetal Alcohol Spectrum Disorders; Fetal Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Disease; Neurodevelopmental Disorders; Pathologic Processes; Mental Disorders; Pregnancy Complications; Substance-Related Disorders; Chemically-Induced Disorders; Ethanol	Choline; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Lipotropic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Lipid Regulating Agents; Nootropic Agents