RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-24
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06379971

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women who report cannabis use during current pregnancy
  1. * Pregnancies complicated by fetal anomaly, including neural tube defect or chromosomal abnormality, or multiple gestations due to increased obstetrical risks
  2. * Women with major preexisting maternal medical morbidities
  3. * Women with a prior history of fetal death
  4. * Current personal history of chronic infections, including HIV
  5. * Current personal or family history out to first-degree relatives of trimethylaminuria or homocystinuria
  6. * Primary language other than English or Spanish
  7. * Evidence of noncompliance

Contacts and Locations

Study Contact

M. Camille Hoffman, MD
CONTACT
303-724-6205
sharon.hunter@cuanschutz.edu
Sharon Hunter, PhD
CONTACT
303-724-6246
sharon.hunter@cuanschutz.edu

Principal Investigator

M. Camille Hoffman, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Sharon Hunter, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado School of Medicine

Study Locations (Sites)

UC Health
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-24
Study Completion Date2029-04

Study Record Updates

Study Start Date2024-10-24
Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

  • phosphatidylcholine
  • choline

Additional Relevant MeSH Terms

  • Child Development
  • Cannabis Use