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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pregnancy Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Participants will take placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Corn oil every day in place of choline

2

Participants will take choline

Group Type ACTIVE_COMPARATOR

Choline

Intervention Type DRUG

900 mg every day until birth of infant

Interventions

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Choline

900 mg every day until birth of infant

Intervention Type DRUG

Placebo

Corn oil every day in place of choline

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Polyenylphosphatidylcholine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes