Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal
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ClinicalTrials.gov Identifier: NCT03028857 |
Recruitment Status :
Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : January 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Child Development Prenatal Stress | Drug: Choline Dietary Supplement: Placebo | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age |
Actual Study Start Date : | June 12, 2017 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
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Placebo Comparator: Participants will take placebo
Participants will take placebo. Corn oil every day in place of choline
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Dietary Supplement: Placebo
Mothers are instructed to take the capsules twice a day, five placebo corn oil capsules at breakfast and five placebo corn oil capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.
Other Name: Corn oil every day in place of choline |
Active Comparator: Drug: Choline
Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery
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Drug: Choline
Mothers are instructed to take the capsules twice a day, five 450 mg phosphatidylcholine capsules at breakfast and five phosphatidylcholine 450 mg capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.
Other Name: Phosphatidylcholine |
- Behavior rated on the Child Behavior Checklist. [ Time Frame: 4 Years of age ]Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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
- Current personal history of chronic infections, including HIV
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Current personal or family history out to first degree relatives of
- Trimethylaminuria
- Homocystinuria
- Primary language other than English or Spanish
- Evidence of noncompliance

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028857
United States, Colorado | |
UCHealth | |
Aurora, Colorado, United States, 80045 | |
Saint Joseph Hospital | |
Denver, Colorado, United States, 80218 |
Principal Investigator: | Camille Hoffman, MD | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT03028857 |
Other Study ID Numbers: |
16-1510 |
First Posted: | January 23, 2017 Key Record Dates |
Last Update Posted: | January 26, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | A copy of the locked database with all outcome, safety, and demographic measures will be provided as a supplement to the primary publication. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Choline Lipotropic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Lipid Regulating Agents Nootropic Agents |