Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development

August 31, 2020 updated by: University of Colorado, Denver

Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels

This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.

Study Overview

Status

Completed

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 900 mg of choline daily throughout pregnancy, until delivery. Babies will then begin receiving either placebo or choline daily from the time of birth until they are 3 months old. Participants will attend a baseline study visit that will include eligibility assessment, urine collection, measurement of vital signs, dispensing of study medication, and an ultrasound. Subsequent study visits will occur every 4 weeks throughout pregnancy and 6 months postpartum. Vital signs will be taken, urine samples will be collected, and study medication will be given at each visit. Two blood samples will be taken between Weeks 32 and 36 of gestation. Heel sticks will be performed on babies when they are 4 and 12 weeks old. Follow-up visits will be held every 6 months until the baby is 18 months old.

Study Type

Interventional

Enrollment (Actual)

351

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
        • University of Colorado Denver

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant
  • Between 10 and 18 weeks gestational age
  • Healthy
  • Diagnosis of psychosis

Exclusion Criteria:

  • Use of any tobacco or nicotine product
  • Drinks more than 1 alcoholic drink per day
  • Use of illicit drugs
  • History of trimethylaminuria
  • History of kidney disease
  • History of liver disease
  • History of pre-pregnancy diabetes
  • History of Parkinson's disease
  • History of fetal death, fetal/infant congenital malformation, or fetal/infant genetic abnormality
  • Evidence of noncompliance to study medication

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: 1
Participants will take placebo
Dietary supplement: Placebo
Corn oil every day in place of choline
Active Comparator: 2
Participants will take choline
Drug: Choline
900 mg every day until birth of infant
Other Names:
  • Polyenylphosphatidylcholine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensory Gaiting (P50)
Time Frame: Measured at birth, 1 month and 3 months after birth
Measured at birth, 1 month and 3 months after birth

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Robert Freedman, MD, University of Colorado, School of Medicine,

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 1, 2006

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 31, 2006

First Posted (Estimate)

June 1, 2006

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0678
  • DATR A5-ETPD

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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