Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Pregnant Women Needed for a Clinical Trial of Choline Supplements

This study looks at how choline supplements and exposure to cannabis-based products affect pregnancy and child health.

Why this Research Matters

This study is looking to see if taking a choline supplement during pregnancy helps with a baby’s brain development as compared to a placebo. Choline is a substance found naturally in foods like milk and eggs. A placebo is a substance that looks the same as the choline supplement but doesn’t have any active ingredients. The placebo for this study is made of pumpkin seed oil. You will randomly be given either the choline supplement or the placebo. Random assignment means that it’s by chance, like flipping a coin. You and the study staff will not know which one you are taking.

What to Expect

You and your child are being asked to join this study. If you join, you will take a supplement or placebo every day during your pregnancy. At study visits, you will fill out surveys, and we will measure your height, weight, and check your vitals. We will also take a small blood sample from your arm using a needle and collect hair and urine samples. At two visits, we will check how well your child is developing. After your baby is born, you will still fill out surveys at the visits, and we will check your baby’s growth and development. We will also collect a urine sample from your baby and a breast milk sample from you.

Study Duration

You will start the study when you are 16 weeks pregnant, and we may continue following you until your child is 4 years old. During your pregnancy, you will have 7 in-person visits about every 6 weeks and 9 phone calls every 2 weeks. After your baby is born, you will have 5 in-person visits, 5 times where you will fill out online surveys, and 14 phone calls until your child is 2 years old. When your child turns 2, you will have 4 in-person visits, 4 phone calls, and 5 times where you fill out online surveys.

Who can Participate

Adults aged 18 to 45.

You may be eligible for this study if you:

  • are between the ages of 18-45
  • are not more than 16 weeks pregnant
  • are not expecting more than one baby
  • have used any cannabis-based product at least once during this pregnancy, even if it was before your pregnancy was confirmed

Study ID

Protocol Number: 23-2327
More information available at ClinicalTrials.gov: NCT06379971

Compensation Information

Compensation
You will get up to $1170.

Meet the Team

Image of Principal Investigator

Maria Hoffman-Shuler, MD, MSc

Principal Investigator

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