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

NCT06379971 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 23-2327
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Development; Cannabis Use

Keywords

phosphatidylcholine; choline

Outcome Measures

Primary Outcomes (2)

• Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index

  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

  3 months corrected age

• Auditory Sensory Gating (P50)

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

  1 month corrected age

Secondary Outcomes (3)

• Maternal Plasma Choline Levels

  approximately 16, 22, 28, 34 weeks gestation

• Bayley Scales of Infant and Toddler Development

  1, 3 and 6 months corrected age

• Child Behavior Checklist (CBCL) 1 1/2-5

  18 months corrected age

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will take 8 placebo capsules each containing 1100mg Rice Bran Oil and 150mg Pumpkin Seed Oil every day in place of phosphatidylcholine supplement.

Drug: Placebo

Phosphatidylcholine

ACTIVE COMPARATOR

Participants will take 8 900mg capsules of phosphatidylcholine every day, the equivalent of approximately 1028 mg of choline per day until delivery

Drug: Choline

Interventions

Placebo DRUG

Pregnant women are instructed to take the capsules twice per day, 4 placebo capsules at breakfast and 4 placebo capsules at dinner. Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.

Also known as: rice bran oil and pumpkin seed oil

Placebo

Choline DRUG

Pregnant women are instructed to take the capsules twice per day, 4 900mg phosphatidylcholine capsules at breakfast and 4 capsules at dinner. Increased awareness Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.

Also known as: Phosphatidylcholine

Phosphatidylcholine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who report cannabis use during current pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UC Health

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Interventions

Rice Bran Oil; Choline; Phosphatidylcholines

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids

Study Officials

• M. Camille Hoffman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Sharon Hunter, PhD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Camille Hoffman, MD

CONTACT

303-724-6205; sharon.hunter@cuanschutz.edu

Sharon Hunter, PhD

CONTACT

303-724-6246; sharon.hunter@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phosphatidylcholine versus placebo

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)