<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/NCT03782935</url>
  </required_header>
  <id_info>
    <org_study_id>080035</org_study_id>
    <nct_id>NCT03782935</nct_id>
  </id_info>
  <brief_title>Nutritional Risk Factors for FASD in Ukraine</brief_title>
  <official_title>Early Identification of Affected Children and Nutritional Risk Factors for FASD in Ukraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Omni-Net Ukraine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interventional study randomizing pregnant women at two sites in Ukraine who have or have not&#xD;
      already consumed moderate to heavy levels of alcohol in pregnancy to receiving a standard&#xD;
      prenatal vitamin supplement with or without additional choline supplement or standard of care&#xD;
      (recommendation to take vitamin supplements) through the remainder of pregnancy, and to&#xD;
      compare neurobehavioral performance of the offspring on the Bayley Scales of Infant&#xD;
      Development at 12 months of age between groups. The overall sample size target was 300&#xD;
      alcohol exposed and 300 low or unexposed across both sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant women coming in for routine prenatal diagnostic testing or prenatal care at two&#xD;
      sites in Ukraine, Rivne Diagnostic Center or Khmelnytsky Regional Perinatal Center, were&#xD;
      screened for alcohol consumption during pregnancy. Those who met the criteria of consuming&#xD;
      4-5 drinks per occasion on 3-4 occasions in either the month around conception or the most&#xD;
      recent month of pregnancy were eligible for recruitment into the alcohol exposed group, and&#xD;
      the next available woman who consumed no more than 2 drinks on any occasion in the month&#xD;
      around conception or the most recent month of pregnancy was eligible for recruitment into the&#xD;
      alcohol low or no exposure group. Within alcohol group and within site, women were randomized&#xD;
      on a 1:1 basis to receiving a study-provided prenatal vitamin (TheraVit) manufactured in the&#xD;
      U.S. and registered in Ukraine as an over-the-counter product, or to receiving standard of&#xD;
      care which is obstetric advice to take prenatal vitamins on their own. Within the group&#xD;
      randomized to receiving the prenatal vitamins, women were further randomized on a 1:1 basis&#xD;
      to receiving an additional 750 mg. of supplemental choline manufactured in the U.S., and&#xD;
      registered in Ukraine as an over-the-counter product.&#xD;
&#xD;
      Women in both cohorts were followed until delivery and those with live born children were&#xD;
      followed until the child reached one year of age. The primary endpoint for the intervention&#xD;
      was performance on the mental developmental index (MDI) and the psychomotor developmental&#xD;
      index (PDI) components of the Bayley Scales of Infant Development II. The Bayley tests were&#xD;
      administered at approximately 12 months adjusted chronological age by trained psychologists&#xD;
      in Ukraine.&#xD;
&#xD;
      The primary comparison for the study was within the alcohol-exposed group, comparing mean&#xD;
      Bayley scores on MDI and separately on PDI between those randomized to receiving the study&#xD;
      prenatal vitamin and those randomized to standard of care.&#xD;
&#xD;
      Secondary comparisons for the study examined&#xD;
&#xD;
        1. the mean MDI and PDI scores on the Bayley within the alcohol-exposed group in those&#xD;
           randomized to receiving the prenatal vitamin plus choline vs. those who received the&#xD;
           prenatal vitamin alone&#xD;
&#xD;
        2. the mean MDI and PDI scores on the Bayley within the low or unexposed group in those who&#xD;
           received the prenatal vitamin vs. those who did not&#xD;
&#xD;
        3. the mean MDI and PDI scores on the Bayley within the low or unexposed group in those who&#xD;
           received the prenatal vitamin plus choline vs. those who received the prenatal vitamin&#xD;
           alone&#xD;
&#xD;
        4. adjusted comparisons for all of the above taking into account participants who were&#xD;
           taking vitamins on their own at the time of enrollment, and/or who were taking vitamins&#xD;
           on their own if assigned to the standard of care group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2006</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Pregnant women assigned to 1) over-the-counter approved prenatal multivitamin mineral supplement alone provided by the study at time of enrollment, 2)over-the-counter approved prenatal multivitamin mineral supplement with additional over-the-counter approved 750 mg choline supplement provided by the study at the time of enrollment, or 3) standard of care which is recommendation to take over-the-counter prenatal multivitamin mineral supplements</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bayley Scales of Infant Development II Mental Developmental Index</measure>
    <time_frame>approximately 12 months of age adjusted for preterm delivery</time_frame>
    <description>Scaled score range 50 to 150 with higher scores indicating better performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bayley Scales of Infant Development III Psychomotor Developmental Index</measure>
    <time_frame>approximately 12 months of age adjusted for preterm delivery</time_frame>
    <description>Scaled score range 50 to 150 with higher scores indicating better performance</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Fetal Alcohol Spectrum Disorders</condition>
  <arm_group>
    <arm_group_label>prenatal multivitamin mineral supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received prenatal multivitamin mineral supplement at time of enrollment TheraVit multivitamin/mineral prenatal supplement with instructions to take 1 per day through the remainder of pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>prenatal multivitamin mineral supplement plus choline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received prenatal multivitamin mineral supplement plus additional choline supplemental vitamin TheraVit multivitamin mineral supplement plus 750 mg. choline with instructions to take1 multivitamin mineral supplement and 750 mg. per day of choline through the remainder of pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Advised to follow obstetrics standard of care which is to take a prenatal vitamin/mineral supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Prenatal multivitamin mineral supplement</intervention_name>
    <description>prenatal vitamin/mineral supplement with or without choline supplement</description>
    <arm_group_label>prenatal multivitamin mineral supplement</arm_group_label>
    <arm_group_label>prenatal multivitamin mineral supplement plus choline</arm_group_label>
    <other_name>Prenatal multivitamin mineral supplement plus choline supplement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  currently pregnant&#xD;
&#xD;
          -  reported alcohol consumption 4-5 drinks per occasion on 3-4 occasions in the month&#xD;
             around conception or the most recent month of pregnancy, or&#xD;
&#xD;
          -  no more than 2 drinks per occasion in either the month around conception or the most&#xD;
             recent month of pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to provide consent&#xD;
&#xD;
          -  unable to provide information about alcohol consumption&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Christina Chambers</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>alcohol</keyword>
  <keyword>pregnancy</keyword>
  <keyword>infant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Alcohol Spectrum Disorders</mesh_term>
  </condition_browse>
  <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>This study is part of a collaborative initiative on Fetal Alcohol Spectrum Disorders and de-identified data is available to share with other researchers on a specified timetable with appropriate application for use.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>2020 and indefinitely</ipd_time_frame>
    <ipd_access_criteria>Application to Collaborative Initiative on Fetal Alcohol Spectrum Disorders data oversight group at CIFASD.org</ipd_access_criteria>
    <ipd_url>http://cifasd.org</ipd_url>
  </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/NCT03782935
org study id: 080035
nct id: NCT03782935
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Interventional study randomizing pregnant women at two sites in Ukraine who have or have not
      already consumed moderate to heavy levels of alcohol in pregnancy to receiving a standard
      prenatal vitamin supplement with or without additional choline supplement or standard of care
      (recommendation to take vitamin supplements) through the remainder of pregnancy, and to
      compare neurobehavioral performance of the offspring on the Bayley Scales of Infant
      Development at 12 months of age between groups. The overall sample size target was 300
      alcohol exposed and 300 low or unexposed across both sites.
Pregnant women coming in for routine prenatal diagnostic testing or prenatal care at two
      sites in Ukraine, Rivne Diagnostic Center or Khmelnytsky Regional Perinatal Center, were
      screened for alcohol consumption during pregnancy. Those who met the criteria of consuming
      4-5 drinks per occasion on 3-4 occasions in either the month around conception or the most
      recent month of pregnancy were eligible for recruitment into the alcohol exposed group, and
      the next available woman who consumed no more than 2 drinks on any occasion in the month
      around conception or the most recent month of pregnancy was eligible for recruitment into the
      alcohol low or no exposure group. Within alcohol group and within site, women were randomized
      on a 1:1 basis to receiving a study-provided prenatal vitamin (TheraVit) manufactured in the
      U.S. and registered in Ukraine as an over-the-counter product, or to receiving standard of
      care which is obstetric advice to take prenatal vitamins on their own. Within the group
      randomized to receiving the prenatal vitamins, women were further randomized on a 1:1 basis
      to receiving an additional 750 mg. of supplemental choline manufactured in the U.S., and
      registered in Ukraine as an over-the-counter product.

      Women in both cohorts were followed until delivery and those with live born children were
      followed until the child reached one year of age. The primary endpoint for the intervention
      was performance on the mental developmental index (MDI) and the psychomotor developmental
      index (PDI) components of the Bayley Scales of Infant Development II. The Bayley tests were
      administered at approximately 12 months adjusted chronological age by trained psychologists
      in Ukraine.

      The primary comparison for the study was within the alcohol-exposed group, comparing mean
      Bayley scores on MDI and separately on PDI between those randomized to receiving the study
      prenatal vitamin and those randomized to standard of care.

      Secondary comparisons for the study examined

        1. the mean MDI and PDI scores on the Bayley within the alcohol-exposed group in those
           randomized to receiving the prenatal vitamin plus choline vs. those who received the
           prenatal vitamin alone

        2. the mean MDI and PDI scores on the Bayley within the low or unexposed group in those who
           received the prenatal vitamin vs. those who did not

        3. the mean MDI and PDI scores on the Bayley within the low or unexposed group in those who
           received the prenatal vitamin plus choline vs. those who received the prenatal vitamin
           alone

        4. adjusted comparisons for all of the above taking into account participants who were
           taking vitamins on their own at the time of enrollment, and/or who were taking vitamins
           on their own if assigned to the standard of care group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pregnant women assigned to 1) over-the-counter approved prenatal multivitamin mineral supplement alone provided by the study at time of enrollment, 2)over-the-counter approved prenatal multivitamin mineral supplement with additional over-the-counter approved 750 mg choline supplement provided by the study at the time of enrollment, or 3) standard of care which is recommendation to take over-the-counter prenatal multivitamin mineral supplements
primary purpose: Prevention
masking: None (Open Label)
measure: Bayley Scales of Infant Development II Mental Developmental Index
time frame: approximately 12 months of age adjusted for preterm delivery
description: Scaled score range 50 to 150 with higher scores indicating better performance
measure: Bayley Scales of Infant Development III Psychomotor Developmental Index
time frame: approximately 12 months of age adjusted for preterm delivery
description: Scaled score range 50 to 150 with higher scores indicating better performance
arm group label: prenatal multivitamin mineral supplement
arm group type: Experimental
description: received prenatal multivitamin mineral supplement at time of enrollment TheraVit multivitamin/mineral prenatal supplement with instructions to take 1 per day through the remainder of pregnancy
arm group label: prenatal multivitamin mineral supplement plus choline
arm group type: Experimental
description: received prenatal multivitamin mineral supplement plus additional choline supplemental vitamin TheraVit multivitamin mineral supplement plus 750 mg. choline with instructions to take1 multivitamin mineral supplement and 750 mg. per day of choline through the remainder of pregnancy
arm group label: Comparison
arm group type: No Intervention
description: Advised to follow obstetrics standard of care which is to take a prenatal vitamin/mineral supplement
intervention type: Dietary Supplement
intervention name: Prenatal multivitamin mineral supplement
description: prenatal vitamin/mineral supplement with or without choline supplement
arm group label: prenatal multivitamin mineral supplement
arm group label: prenatal multivitamin mineral supplement plus choline
other name: Prenatal multivitamin mineral supplement plus choline supplement
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Christina Chambers
investigator title: Professor of Pediatrics
mesh term: Fetal Alcohol Spectrum Disorders
mesh term: Choline
sharing ipd: Yes
ipd description: This study is part of a collaborative initiative on Fetal Alcohol Spectrum Disorders and de-identified data is available to share with other researchers on a specified timetable with appropriate application for use.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: 2020 and indefinitely
ipd access criteria: Application to Collaborative Initiative on Fetal Alcohol Spectrum Disorders data oversight group at CIFASD.org
ipd url: http://cifasd.org