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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT00332124
Collaborator
(none)
351
Enrollment
1
Location
2
Arms
129
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
351 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels
Actual Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensory Gaiting (P50) [Measured at birth, 1 month and 3 months after birth]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT00332124
    Other Study ID Numbers:
    • 04-0678
    • DATR A5-ETPD
    First Posted:
    Jun 1, 2006
    Last Update Posted:
    Sep 2, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Choline

    Study Results

    No Results Posted as of Sep 2, 2020