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Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

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ClinicalTrials.gov Identifier: NCT03028857
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Child Development Prenatal Stress Drug: Choline Dietary Supplement: Placebo Phase 1

Detailed Description:

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 Design
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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 : January 2027
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Participants will take placebo
Participants will take placebo. Corn oil every day in place of choline
 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.
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
 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.
Other Name: Phosphatidylcholine


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Camille Hoffman, MD 303-724-6205 victoria.k.walker@cuanschutz.edu
Contact: Victoria Walker, RN 303-724-6200 victoria.k.walker@cuanschutz.edu

Locations
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United States, Colorado
UCHealth Recruiting
Aurora, Colorado, United States, 80045
Contact: Victoria Walker, RN       VICTORIA.K.WALKER@CUANSCHUTZ.EDU   
Saint Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Victoria Walker, RN       VICTORIA.K.WALKER@CUANSCHUTZ.EDU   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Camille Hoffman, MD University of Colorado, Denver
More Information
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Publications:

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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: October 8, 2020
Last Verified: October 2020
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents