Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure - Full Text View

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Resource links provided by NLM:

MedlinePlus related topics: Fetal Alcohol Spectrum Disorders

Drug Information available for: Choline chloride Choline bitartrate

Genetic and Rare Diseases Information Center resources: Fetal Alcohol Spectrum Disorders

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Side Effects of Choline Bitartrate [ Time Frame: Baseline, 6 months, & 9 months ] [ Designated as safety issue: Yes ]
Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Mullen Scales of Early Learning - Early Learning Composite [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
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:

Elicited Imitation Task Memory [ Time Frame: Baseline, 6 months, and 9 months ] [ Designated as safety issue: No ]
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.
Evoked Response Potentials [ Time Frame: Baseline, 6 months, and 9 months ] [ Designated as safety issue: No ]
Evoked response potentials were measured for the memory task and a separate visually-evoked response task (a measure of processing speed). The volume of data collected was quite large and turned out to be a significant challenges for analysis. ERP data were collected from 128 electrodes on the head. Several ERP components were considered for these exploratory analyses including NC (latency and peak amplitude) as well as PSW (latency and peak amplitude). For VEP, P100 was considered. Because these analyses were not primary, and because of complications in the analyses, these data have not yet been finalized or published. The data, in their current state, do not lend themselves to inclusion here.


Enrollment:	60
Study Start Date:	July 2010
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	2 Years to 5 Years (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149538

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

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
Study First Received:	June 21, 2010
Results First Received:	February 29, 2016
Last Updated:	June 30, 2016
Health Authority:	United States: Food and Drug Administration

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 Ethanol Disease Neurodevelopmental Disorders Pathologic Processes Pregnancy Complications Substance-Related Disorders Chemically-Induced Disorders Mental Disorders	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

ClinicalTrials.gov processed this record on September 29, 2016