<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03028857</url>
  </required_header>
  <id_info>
    <org_study_id>16-1510</org_study_id>
    <nct_id>NCT03028857</nct_id>
  </id_info>
  <brief_title>Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal</brief_title>
  <official_title>Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to&#xD;
      pregnant women improves early brain development with improved brain-related development&#xD;
      during the first four years of life. Participating pregnant women will receive either&#xD;
      phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The&#xD;
      primary outcome is the child's behavior at four years of age as reported by the primary&#xD;
      caregiver. Secondary outcomes include motor development, socio-emotional development,&#xD;
      language development, and cognitive development. Potential contributors beyond the&#xD;
      supplement, including maternal stress and placental function will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and&#xD;
      other meats. It is important for the composition and repair of normal cellular membranes,&#xD;
      normal brain function, and normal cardiovascular function. Research has suggested that the&#xD;
      presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure&#xD;
      healthy fetal brain development. Additionally, adequate prenatal choline levels may have&#xD;
      long-lasting positive effects on cognitive function, including memory. However, sufficient&#xD;
      research has not been done on the effects of choline on pregnant women and their unborn&#xD;
      babies. This study will evaluate the safety and effectiveness of taking choline supplements&#xD;
      during pregnancy, and whether taking choline during pregnancy will have an effect on infant&#xD;
      development.&#xD;
&#xD;
      Participants in this double-blind study will be randomly assigned to receive either placebo&#xD;
      or 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken,&#xD;
      potential side effects will be assessed, and study medication will be given at each visit.&#xD;
      Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children&#xD;
      will be followed and assessed until 4 years of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavior rated on the Child Behavior Checklist.</measure>
    <time_frame>4 Years of age</time_frame>
    <description>Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Child Development</condition>
  <condition>Prenatal Stress</condition>
  <arm_group>
    <arm_group_label>Participants will take placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take placebo. Corn oil every day in place of choline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: Choline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Choline</intervention_name>
    <description>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.</description>
    <arm_group_label>Drug: Choline</arm_group_label>
    <other_name>Phosphatidylcholine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>Participants will take placebo</arm_group_label>
    <other_name>Corn oil every day in place of choline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General Health: Other than pregnancy related illnesses, physically healthy expectant&#xD;
             mothers&#xD;
&#xD;
          -  ages 18-45 years&#xD;
&#xD;
          -  prepregnancy BMI&gt;18 and &lt;45&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of fetal death&#xD;
&#xD;
          -  Current personal history of chronic infections, including HIV&#xD;
&#xD;
          -  Current personal or family history out to first degree relatives of&#xD;
&#xD;
               1. Trimethylaminuria&#xD;
&#xD;
               2. Homocystinuria&#xD;
&#xD;
          -  Primary language other than English or Spanish&#xD;
&#xD;
          -  Evidence of noncompliance&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camille Hoffman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCHealth</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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. Erratum In: Am J Psychiatry. 2016 Jul 1;173(7):735.</citation>
    <PMID>26651393</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A copy of the locked database with all outcome, safety, and demographic measures will be provided as a supplement to the primary publication.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028857
org study id: 16-1510
nct id: NCT03028857
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Behavior rated on the Child Behavior Checklist.
time frame: 4 Years of age
description: Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.
arm group label: Participants will take placebo
arm group type: Placebo Comparator
description: Participants will take placebo. Corn oil every day in place of choline
arm group label: Drug: Choline
arm group type: Active Comparator
description: Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery
intervention type: Drug
intervention name: Choline
description: 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.
arm group label: Drug: Choline
other name: Phosphatidylcholine
intervention type: Dietary Supplement
intervention name: Placebo
description: 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.
arm group label: Participants will take placebo
other name: Corn oil every day in place of choline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Camille Hoffman, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
country: United States
citation: 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. Erratum In: Am J Psychiatry. 2016 Jul 1;173(7):735.
PMID: 26651393
responsible party type: Sponsor
mesh term: Choline
sharing ipd: Yes
ipd description: A copy of the locked database with all outcome, safety, and demographic measures will be provided as a supplement to the primary publication.