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

Description

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.

Conditions

Child Development, Cannabis Use

Study Overview

Study Details

Study overview

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.

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

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

Condition
Child Development
Intervention / Treatment

-

Contacts and Locations

Aurora

UC Health, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pregnant women who report cannabis use during current pregnancy
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Colorado, Denver,

M. Camille Hoffman, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Sharon Hunter, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado School of Medicine

Study Record Dates

2029-04