Maternal Choline Supplementation and Cannabis Use During Pregnancy

This study is looking at whether a nutritional supplement called phosphatidylcholine can help with brain development in babies whose mothers used cannabis during pregnancy. Pregnant women who have used cannabis will receive either phosphatidylcholine or a placebo (an inactive substance) from about 16 weeks of pregnancy until birth. Researchers will then look at the baby's brain responses to sound at 1 month corrected age and their behaviors at 3 months corrected age. The study aims to enroll 140 women between 18 and 45 years old who are pregnant and have used cannabis during this pregnancy. Women with certain medical conditions or fetal anomalies cannot participate. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 140 women. Participants will be randomly assigned to receive either phosphatidylcholine or a placebo, and neither they nor the researchers will know which they are receiving (double-blind).
What's involved
Pregnant women will take capsules twice per day from approximately 16 weeks gestation through birth. Vital signs will be taken, and potential side effects will be assessed at each visit.
Compensation
Not stated in the trial record.
Follow-up
Babies' development will be assessed at 1 month corrected age and 3 months corrected age after birth.

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NCT06379971

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

Recruiting
PHASE1Ages 18–45InterventionalPrevention
University of Colorado, Denver
~140 participants
Updated 2025-02-03 on ClinicalTrials.gov
What's tested:PlaceboCholine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index
Measured over 3 months corrected age
+1 more outcome measured
Child Development
Cannabis Use
1 sites across 1 states
Colorado1
  • M. Camille Hoffman, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
  • Sharon Hunter, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado School of Medicine

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Eligibility criteria

Inclusion

Pregnant women who report cannabis use during current pregnancy

Exclusion

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
  • Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index3 months corrected age

    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

  • Auditory Sensory Gating (P50)1 month corrected age

    Inhibition of the P50 cerebral auditory evoked response is collected during a paired stimulus auditory sensory gating paradigm