<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/NCT03283579</url>
  </required_header>
  <id_info>
    <org_study_id>mlopez</org_study_id>
    <nct_id>NCT03283579</nct_id>
  </id_info>
  <brief_title>Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms</brief_title>
  <official_title>Prenatal Omega-6/Omega-3 Ratio and Attention Deficit and Hyperactivity Disorder Symptoms in Children: a Population-based Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barcelona Institute for Global Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barcelona Institute for Global Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in&#xD;
      cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA&#xD;
      project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was&#xD;
      associated with higher subclinical ADHD symptoms during early and mid-childhood.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2003</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fatty acid ratio in cord blood</measure>
    <time_frame>2004-2008</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ADHD 4 years old</measure>
    <time_frame>2008-2012</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ADHD 7 years old</measure>
    <time_frame>2012-2016</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2644</enrollment>
  <condition>Child Behavior Problem</condition>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <condition>Fatty Acid Deficiency</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study was based on data from a population-based birth cohort, INMA (Infancia y Medio&#xD;
        Ambiente [Environment and Childhood]) project, including four Spanish regions: Asturias&#xD;
        (n=494) and Gipuzkoa (Basque Country) (n=638) on the Cantabrian coast, and Sabadell&#xD;
        (Catalonia) (n=657) and Valencia (n=855) on the Mediterranean coast.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age 16 years or older&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  No use of assisted reproductive techniques&#xD;
&#xD;
          -  Intention to deliver at the reference hospital&#xD;
&#xD;
          -  Ability to speak and understand Spanish or a local language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03283579
org study id: mlopez
nct id: NCT03283579
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in
      cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA
      project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was
      associated with higher subclinical ADHD symptoms during early and mid-childhood.
observational model: Cohort
time perspective: Prospective
measure: Fatty acid ratio in cord blood
time frame: 2004-2008
measure: ADHD 4 years old
time frame: 2008-2012
measure: ADHD 7 years old
time frame: 2012-2016
arm group label: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Problem Behavior
sharing ipd: No