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Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00332124 |
This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.
Condition | Intervention | Phase |
---|---|---|
Pregnancy Child Development |
Dietary Supplement: Choline Dietary Supplement: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels |
Estimated Enrollment: | 258 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Participants will take placebo
|
Dietary Supplement: Placebo
Corn oil every day in place of choline
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2: Active Comparator
Participants will take choline
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Dietary Supplement: Choline
900 mg every day until birth of infant
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julie Beuler, RN | 303.724.6205 | julie.beuler@uchsc.edu |
United States, Colorado | |
University of Colorado at Denver Health Science Center | Recruiting |
Denver, Colorado, United States, 80262 | |
Contact: Julie Beuler, RN julie.beuler@uchsc.edu | |
Principal Investigator: Randy Ross, MD |
Principal Investigator: | Randy Ross, MD | University of Colorado Health Sciences Center, Department of Psychiatry |
Responsible Party: | University of Colorado - Denver ( Randall G. Ross, MD ) |
Study ID Numbers: | P50 MH77136, DATR A5-ETPD |
Study First Received: | May 30, 2006 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00332124 |
Health Authority: | United States: Food and Drug Administration |
Choline |
Antimetabolites Nootropic Agents Lipotropic Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Gastrointestinal Agents Central Nervous System Agents Pharmacologic Actions |