Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 12/21/2018 |
| Start Date: | June 12, 2017 |
| End Date: | January 2027 |
| Contact: | Camille Hoffman, MD |
| Email: | anna.wyrwa@ucdenver.edu |
| Phone: | 3037246205 |
Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age
The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to
pregnant women improves early brain development with improved brain-related development
during the first four years of life. Participating pregnant women will receive either
phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The
primary outcome is the child's behavior at four years of age as reported by the primary
caregiver. Secondary outcomes include motor development, socio-emotional development,
language development, and cognitive development. Potential contributors beyond the
supplement, including maternal stress and placental function will also be assessed.
pregnant women improves early brain development with improved brain-related development
during the first four years of life. Participating pregnant women will receive either
phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The
primary outcome is the child's behavior at four years of age as reported by the primary
caregiver. Secondary outcomes include motor development, socio-emotional development,
language development, and cognitive development. Potential contributors beyond the
supplement, including maternal stress and placental function will also be assessed.
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 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken,
potential side effects will be assessed, and study medication will be given at each visit.
Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children
will be followed and assessed until 4 years of age.
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 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken,
potential side effects will be assessed, and study medication will be given at each visit.
Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children
will be followed and assessed until 4 years of age.
Inclusion Criteria:
- General Health: Other than pregnancy related illnesses, physically healthy expectant
mothers
- ages 18-45 years
- prepregnancy BMI>18 and <45
Exclusion Criteria:
- Prior history of fetal death
- Maternal use of more than 1 drink per day of alcohol
- Maternal use of illicit drugs, not including cannabis
- Maternal chronic chronic steroid use
- Current personal history of
1. Chronic neurological illness, including Parkinson's
2. Chronic infections, including HIV
3. Suicidal ideation
- Current personal or family history out to first degree relatives of
1. Trimethylaminuria
2. Homocystinuria
- Primary language other than English or Spanish
- Evidence of noncompliance
- Use of supplements other than a standard daily multivitamin such as
1. a prenatal vitamin and/or
2. omega-3 fatty acid supplement.
We found this trial at
1
site
Click here to add this to my saved trials
