At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Choline bitartrate +1 moredrug
Likely dose
Choline bitartrate 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
In Brief
A Phase 2 clinical trial evaluating Choline bitartrate and Placebo for choline bitartrate for Fetal Alcohol Spectrum Disorders and 4 related conditions. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Prenatal Alcohol Exposure
CountriesUnited States
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartJul 2010
Primary CompletionSep 2014
TodayJul 2026
First PostedJun 23, 2010
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.0 years ago
Interventions
Choline bitartratedrug
Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Placebo for choline bitartratedietary
Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.