Phase 2
N=60
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders · Fetal Alcohol Syndrome · Partial Fetal Alcohol Syndrome · Alcohol Related Neurodevelopmental Disorder · Prenatal Alcohol Exposure
Bottom Line
View on ClinicalTrials.gov: NCT01149538 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Side Effects of Choline Bitartrate — 8; 10; 8; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Choline bitartrate (Drug); Placebo for choline bitartrate (Dietary_supplement)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Side Effects of Choline Bitartrate |
8; 10; 8; 9; 8; 9 | — |
| PRIMARY Mullen Scales of Early Learning - Early Learning Composite |
83.2; 84.3; 87.1; 89.6 | — |
| SECONDARY Elicited Imitation Task Memory |
14.24; 4.43; -.71; 4.23; 18.97; 10.39 | — |
| SECONDARY Evoked Response Potentials Microvolts |
-2.05; 0.57; -1.04; -1.03; -0.26; -1.41 | — |
| SECONDARY Evoked Response Potential - Negative Component Latency |
2.23; 5.35; 32.45; -4.28; -4.00; -3.03 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01149538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.