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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


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
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