Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01149538
First received: June 21, 2010
Last updated: September 4, 2014
Last verified: September 2014
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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:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Side Effects of Choline Bitartrate [ Time Frame: 14 days, 1, 2, 3, 4, 5, 6, 7, 8 and 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 [ Time Frame: Baseline, 6 months, 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.
Secondary Outcome Measures:
- Elicited Imitation Task Memory [ Time Frame: Baseline, 6 months, and 9 months ] [ Designated as safety issue: No ]An Elicited Imtation paradigm will be used to measure memory in the participants (immediate, delayed, interleaved).
- Evoked Response Potentials [ Time Frame: Baseline, 6 months, and 9 months ] [ Designated as safety issue: No ]Evoked response potentials will be measured for the memory task and a separate visually-evoked response task (a measure of processing speed).
| 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 |
| 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
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
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
No publications provided
| 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 |
| Last Updated: | September 4, 2014 |
| 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:
|
Fetal Alcohol Spectrum Disorders Alcohol-Induced Disorders Alcohol-Related Disorders Fetal Diseases Chemically-Induced Disorders Pregnancy Complications Substance-Related Disorders Choline Antimetabolites |
Central Nervous System Agents Gastrointestinal Agents Hypolipidemic Agents Lipid Regulating Agents Lipotropic Agents Molecular Mechanisms of Pharmacological Action Nootropic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015