Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

NCT03028857 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 16-1510
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief Summary

The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.

Conditions

Child Development; Prenatal Stress

Outcome Measures

Primary Outcomes (1)

• Behavior rated on the Child Behavior Checklist.

  Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.

  4 Years of age

Study Arms (2)

Participants will take placebo

PLACEBO COMPARATOR

Participants will take placebo. Corn oil every day in place of choline

Drug: Placebo

Drug: Choline

ACTIVE COMPARATOR

Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery

Drug: Choline

Interventions

Choline DRUG

Mothers are instructed to take the capsules twice a day, five 450 mg phosphatidylcholine capsules at breakfast and five phosphatidylcholine 450 mg capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.

Also known as: Phosphatidylcholine

Drug: Choline

Placebo DRUG

Mothers are instructed to take the capsules twice a day, five placebo corn oil capsules at breakfast and five placebo corn oil capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.

Also known as: Corn oil every day in place of choline

Participants will take placebo

Eligibility Criteria

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

You may qualify if:

• General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
• ages 18-45 years
• prepregnancy BMI\>18 and \<45

You may not qualify if:

• 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
• Homocystinuria
• Primary language other than English or Spanish
• Evidence of noncompliance

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

UCHealth

Aurora, Colorado, 80045, United States

Location

Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Related Publications (1)

• Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7.

  PMID: 26651393 BACKGROUND

MeSH Terms

Interventions

Choline; Phosphatidylcholines

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• Camille Hoffman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: June 12, 2017
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)