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

Primary Objective

The purpose of the study is to see if a dietary supplement helps improve early brain development in fetuses of pregnant women who use cannabis products.

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Description

Have an in-person appointment every six weeks and a telephone call every two weeks starting around 16-weeks gestation up until birth. Take the study supplement by mouth every morning and evening until birth. Have 5 in-person appointments and once monthly telephone calls about your child’s development from birth until your child is 2. Have 4 in-person appointments and 4 phone calls between your child’s 2nd and 4th birthdays.To make sure you're eligible, we may review your UCHealth medical record. You will be compensated for your participation.

Details
Age
Child to Adult
Eligibility
Are pregnant and less than 16 weeks along. Are between the ages of 18 and 45. Have used cannabis products during the current pregnancy. Other than pregnancy-related illnesses, physically healthy expectant mothers between ages 18-45 years with singleton pregnancies, who report ANY cannabis product (CBD, THC) use during the current pregnancy. Use does not have to be ongoing.
Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Camille Hoffman-Shuler

Camille Hoffman-Shuler

Study ID

Protocol Number: 23-2327

More information available at ClinicalTrials.gov: NCT06379971

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