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

NCT ID: NCT06379971

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2029-04-30

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'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'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.

Conditions

Child Development; Cannabis Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Participants will take 8 placebo capsules each containing 1100mg Rice Bran Oil and 150mg Pumpkin Seed Oil every day in place of phosphatidylcholine supplement.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Phosphatidylcholine

Participants will take 8 900mg capsules of phosphatidylcholine every day, the equivalent of approximately 1028 mg of choline per day until delivery

Group Type: ACTIVE_COMPARATOR

Choline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

rice bran oil and pumpkin seed oil; Phosphatidylcholine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Camille Hoffman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Sharon Hunter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

UC Health

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

M. Camille Hoffman, MD

Role: CONTACT

sharon.hunter@cuanschutz.edu

303-724-6205

Sharon Hunter, PhD

Role: CONTACT

sharon.hunter@cuanschutz.edu

303-724-6246

Facility Contacts

Sharon Hunter, PhD

Role: primary

sharon.hunter@cuanschutz.edu

303-724-6246

Other Identifiers

23-2327

Identifier Type: -

Identifier Source: org_study_id