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

Study Overview
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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.

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.

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

Conditions
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Pregnancy, Child Development

Intervention / Treatment
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* Drug: Choline
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Participants will take placebo | Dietary Supplement: Placebo<br>* Corn oil every day in place of choline<br>|
| Active Comparator: 2<br>Participants will take choline | Drug: Choline<br>* 900 mg every day until birth of infant<br>* Other names: Polyenylphosphatidylcholine;|

What is the study measuring?
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Primary Outcome Measures

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