Clinical trial NCT06379971: Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
Official title: Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Child Development
Cannabis Use
Keywords: phosphatidylcholine
choline
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phosphatidylcholine versus placebo
Primary purpose: PREVENTION

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 offspring\&#39;s 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 child\&#39;s 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who report cannabis use during current pregnancy

Exclusion Criteria:

* Pregnancies complicated by fetal anomaly, including neural tube defect or chromosomal abnormality, or multiple gestations due to increased obstetrical risks
* Women with major preexisting maternal medical morbidities
* Women with a prior history of fetal death
* Current personal history of chronic infections, including HIV
* Current personal or family history out to first-degree relatives of trimethylaminuria or homocystinuria
* Primary language other than English or Spanish
* Evidence of noncompliance

Primary outcomes:
measure: Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index
timeFrame: 3 months corrected age
measure: Auditory Sensory Gating (P50)
timeFrame: 1 month corrected age
Secondary outcomes:
measure: Maternal Plasma Choline Levels
timeFrame: approximately 16, 22, 28, 34 weeks gestation
measure: Bayley Scales of Infant and Toddler Development
timeFrame: 1, 3 and 6 months corrected age
measure: Child Behavior Checklist (CBCL) 1 1/2-5
timeFrame: 18 months corrected age
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UC Health
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: M. Camille Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado School of Medicine
name: Sharon Hunter, PhD
role: PRINCIPAL_INVESTIGATOR
References: