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| ID | Type | Description | Link |
|---|---|---|---|
| DATR A5-ETPD |
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This study will evaluate the safety and effectiveness of taking choline supplements during 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Participants will take placebo |
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| 2 | Active Comparator | Participants will take choline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline | Drug | 900 mg every day until birth of infant |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Sensory Gaiting (P50) | Measured at birth, 1 month and 3 months after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Freedman, MD | University of Colorado, School of Medicine, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26651393 | Derived | Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7. | |
| 23318559 | Derived |
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| ID | Term |
|---|---|
| D002794 | Choline |
| C005152 | lipostabil |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Dietary Supplement | Corn oil every day in place of choline |
|
| Ross RG, Hunter SK, McCarthy L, Beuler J, Hutchison AK, Wagner BD, Leonard S, Stevens KE, Freedman R. Perinatal choline effects on neonatal pathophysiology related to later schizophrenia risk. Am J Psychiatry. 2013 Mar;170(3):290-8. doi: 10.1176/appi.ajp.2012.12070940. |
| D000588 |
| Amines |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |