Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332124
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2006-05-30
Brief Title:
Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 function and normal cardiovascular function Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development Additionally adequate prenatal choline levels may have long-lasting positive effects on cognitive function including memory However sufficient research has not been done on the effects of choline on pregnant women and their unborn babies This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy and whether taking choline during pregnancy will have an effect on infant development
Participants in this double-blind study will be randomly assigned to receive either placebo or 900 mg of choline daily throughout pregnancy until delivery Babies will then begin receiving either placebo or choline daily from the time of birth until they are 3 months old Participants will attend a baseline study visit that will include eligibility assessment urine collection measurement of vital signs dispensing of study medication and an ultrasound Subsequent study visits will occur every 4 weeks throughout pregnancy and 6 months postpartum Vital signs will be taken urine samples will be collected and study medication will be given at each visit Two blood samples will be taken between Weeks 32 and 36 of gestation Heel sticks will be performed on babies when they are 4 and 12 weeks old Follow-up visits will be held every 6 months until the baby is 18 months old
Participants in this double-blind study will be randomly assigned to receive either placebo or 900 mg of choline daily throughout pregnancy until delivery Babies will then begin receiving either placebo or choline daily from the time of birth until they are 3 months old Participants will attend a baseline study visit that will include eligibility assessment urine collection measurement of vital signs dispensing of study medication and an ultrasound Subsequent study visits will occur every 4 weeks throughout pregnancy and 6 months postpartum Vital signs will be taken urine samples will be collected and study medication will be given at each visit Two blood samples will be taken between Weeks 32 and 36 of gestation Heel sticks will be performed on babies when they are 4 and 12 weeks old Follow-up visits will be held every 6 months until the baby is 18 months old
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A5-ETPD | None | None | None |