Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379971
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-18
Brief Title:
Maternal Choline Supplementation and Cannabis Use During Pregnancy Impact on Early Brain Development
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The goal of this study is to determine if providing a nutritional supplement phosphatidylcholine to pregnant women who have used cannabis products during the current pregnancy improves the offspring39s brain-related development during the first 3 months Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth The primary outcomes are the child39s brain responses to sound at 4 weeks corrected age and infant behaviors at 3 months corrected age as reported by the primary caregiver Secondary outcomes include motor socio-emotional language and cognitive development
Detailed Description:
Phosphatidylcholine PC is a form of choline a nutrient that is sometimes referred to as Vitamin B4 or Vitamin J Choline is for normal growth everywhere in the body including in the brain PC is a naturally occurring substance and can be found in many different kinds of food including milk liver and eggs so most people get enough choline However when a woman is pregnant and her baby is growing many new cells more PC may be needed Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development and may have long-lasting positive effects on cognitive function Problems in behavioral and cognitive development into childhood have been reported in children of mothers who used cannabis during gestation Alternatively two studies of maternal choline levels during pregnancy have reported beneficial effects of higher levels on childhood behavioral and cognitive development This study assesses whether a higher dose of choline taken during pregnancy will have positive results on offspring development
Participants in this double-blind study will be randomly assigned to receive either placebo or 1028 mg of choline daily throughout pregnancy until delivery Vital signs will be taken potential side effects will be assessed and study medication will be given at each visit Blood samples will be taken at enrollment and approximately at weeks 16 22 28 34 Children will be followed and assessed until 3 months of age
Participants in this double-blind study will be randomly assigned to receive either placebo or 1028 mg of choline daily throughout pregnancy until delivery Vital signs will be taken potential side effects will be assessed and study medication will be given at each visit Blood samples will be taken at enrollment and approximately at weeks 16 22 28 34 Children will be followed and assessed until 3 months of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None