Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149538
• Other study ID #: 0910M73517
• Secondary ID: R21AA019580
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 21, 2010
• Last updated: September 4, 2014
• Start date: July 2010
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Related Neurodevelopmental Disorder
• Disease
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Mental Disorders Diagnosed in Childhood
• Partial Fetal Alcohol Syndrome
• Prenatal Alcohol Exposure
• Syndrome

Intervention

Drug:
• Choline bitartrate
Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.

Dietary Supplement:
• Placebo for choline bitartrate
Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side Effects of Choline Bitartrate	Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.	14 days, 1, 2, 3, 4, 5, 6, 7, 8 and 9 months	Yes
Primary	Mullen Scales of Early Learning	The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure.	Baseline, 6 months, and 9 months	No
Secondary	Elicited Imitation Task Memory	An Elicited Imtation paradigm will be used to measure memory in the participants (immediate, delayed, interleaved).	Baseline, 6 months, and 9 months	No
Secondary	Evoked Response Potentials	Evoked response potentials will be measured for the memory task and a separate visually-evoked response task (a measure of processing speed).	Baseline, 6 months, and 9 months	No