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

Phase 1

Completed

• Conditions: Pregnancy; Child Development
• Interventions: Dietary Supplement: Placebo; Drug: Choline

• Registration Number: NCT00332124
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-31
• Study Start: 2006-06
• Study First Posted: 2006-06-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 351

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Participants will take placebo
2	Choline	Participants will take choline

Primary Outcome Measures

Name	Time	Method
Sensory Gaiting (P50)	Measured at birth, 1 month and 3 months after birth

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States