Trials / Completed
CompletedNCT01149538
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Fetal Alcohol Spectrum Disorders
- Fetal Alcohol Syndrome
- Partial Fetal Alcohol Syndrome
- Alcohol Related Neurodevelopmental Disorder
- Prenatal Alcohol Exposure
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2010-06-23
- Last updated
- 2016-12-19
- Results posted
- 2016-08-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01149538. Inclusion in this directory is not an endorsement.