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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332124
• Other study ID #: 04-0678
• Secondary ID: DATR A5-ETPD
• Status: Completed
• Phase: Phase 1
• Start date: June 2006
• Est. completion date: March 2017

Study information

• Verified date: August 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Pregnancy

Intervention

Drug:
• Choline
900 mg every day until birth of infant

Dietary Supplement:
• Placebo
Corn oil every day in place of choline

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory Gaiting (P50)		Measured at birth, 1 month and 3 months after birth