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

University of Colorado, Denver · NCT06379971

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
140
US sites recruiting
1
Study start
November 25, 2024
Record last updated
February 3, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Placebo; Choline

Conditions: Child Development; Cannabis Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • UC Health

    Aurora, CO 80045

    Site contact: Sharon Hunter, PhD · 303-724-6246 · sharon.hunter@cuanschutz.edu

Study contacts (from the official record)

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