Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development

Child Development Clinical Trial

Official title:

Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379971
• Other study ID #: 23-2327
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: April 2029

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: M. Camille Hoffman, MD
• Phone: 303-724-6205
• Email: sharon.hunter[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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's brain-related development during the first 18 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child's brain responses to sound at 4 weeks corrected age, and infant behaviors at 3 months and 18 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development.

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 18 months of age.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use
• Child Development
• Marijuana Abuse

Intervention

Dietary Supplement:
• Placebo
Pregnant women are instructed to take the capsules twice per day, 4 placebo capsules at breakfast and 4 placebo capsules at dinner. Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.

Drug:
• Choline
Pregnant women are instructed to take the capsules twice per day, 4 900mg phosphatidylcholine capsules at breakfast and 4 capsules at dinner. Increased awareness Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.

Locations

Country	Name	City	State
United States	UC Health	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index	The Orienting/Regulation Index is derived by adding the maternal rating of the infant's duration of attention, distractibility, soothability, cuddling, and smiling on the 91-item IBQ-r	3 months corrected age
Primary	Auditory Sensory Gating (P50)	Inhibition of the P50 cerebral auditory evoked response is collected during a paired stimulus auditory sensory gating paradigm	1 month corrected age
Primary	Child Behavior Checklist (CBCL) 1 1/2-5	The CBCL assesses a wide range of parent reported behaviors in children on a normative scale for comparison with others, including those assessed in need of clinical interventions for behavioral problems	18 months corrected age
Secondary	Maternal Plasma Choline Levels	Plasma choline levels will be used to assess the effects of supplementation throughout gestation	approximately 16, 22, 28, 34 weeks gestation
Secondary	Bayley Scales of Infant and Toddler Development	The Bayley Scales are a standardized assessment of language, cognitive and motor development	1, 3 and 6 months corrected age