Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development
| Status: | Suspended |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | June 2006 |
| End Date: | March 2017 |
Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels
This study will evaluate the safety and effectiveness of taking choline supplements during
pregnancy, and whether choline supplementation has an effect on infant development.
pregnancy, and whether choline supplementation has an effect on infant development.
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.
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.
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
We found this trial at
1
site
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
Click here to add this to my saved trials
