Status:
COMPLETED
Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development
Lead Sponsor:
University of Colorado, Denver
Conditions:
Pregnancy
Child Development
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.
Detailed Description
Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain functi...
Eligibility Criteria
Inclusion
- Pregnant
- Between 10 and 18 weeks gestational age
- Healthy
- Diagnosis of psychosis
Exclusion
- Use of any tobacco or nicotine product
- Drinks more than 1 alcoholic drink per day
- Use of illicit drugs
- History of trimethylaminuria
- History of kidney disease
- History of liver disease
- History of pre-pregnancy diabetes
- History of Parkinson's disease
- History of fetal death, fetal/infant congenital malformation, or fetal/infant genetic abnormality
- Evidence of noncompliance to study medication
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00332124
Start Date
June 1 2006
End Date
March 1 2017
Last Update
September 2 2020
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045