Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

September 25, 2023 updated by: University of Colorado, Denver

Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.

Participants in this double-blind study will be randomly assigned to receive either placebo or 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken, potential side effects will be assessed, and study medication will be given at each visit. Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children will be followed and assessed until 4 years of age.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UCHealth
      • Denver, Colorado, United States, 80218
        • Saint Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior history of fetal death
  • Current personal history of chronic infections, including HIV

  • Current personal or family history out to first degree relatives of

    1. Trimethylaminuria
    2. Homocystinuria
  • Primary language other than English or Spanish
  • Evidence of noncompliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Participants will take placebo
Participants will take placebo. Corn oil every day in place of choline
Dietary supplement: Placebo
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.
Other Names:
  • Corn oil every day in place of choline
Active Comparator: Drug: Choline
Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery
Drug: Choline
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.
Other Names:
  • Phosphatidylcholine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavior rated on the Child Behavior Checklist.
Time Frame: 4 Years of age
Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.
4 Years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Camille Hoffman, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimated)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A copy of the locked database with all outcome, safety, and demographic measures will be provided as a supplement to the primary publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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