<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/NCT02248948</url>
  </required_header>
  <id_info>
    <org_study_id>ECOMEGA-TDAH-014</org_study_id>
    <secondary_id>2013-004638-14</secondary_id>
    <nct_id>NCT02248948</nct_id>
  </id_info>
  <brief_title>Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children</brief_title>
  <acronym>ECOMEGA</acronym>
  <official_title>Multicenter Randomized Controlled Trial for the Evaluation of Superiority of a Supplement With Omega-3 Fatty Acids Versus Placebo for the Improvement of Attention Deficit and Hyperactivity Disorder (ADHD) in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratorios Ordesa</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clever Instruments S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Laboratorios Ordesa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the&#xD;
      Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind&#xD;
      study to evaluate the effect of an Omega-3 Fatty Acid Supplement with EPA, DHA, vitamins E&#xD;
      and D on ADHD clinical symptoms (according to Diagnostic and Statistical Manual for Mental&#xD;
      Disorders, 4th. edition (DSM-IV-TR) criteria) in children between 6 and 11 years. Patients&#xD;
      will be randomized to receive either the new omega-3 supplement or a placebo during 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in clinical symptoms of ADHD</measure>
    <time_frame>At baseline and at 6 months</time_frame>
    <description>Differences between groups measured by:&#xD;
Number of criteria of the ADHD-Scale-IV rated by parents and teachers&#xD;
Clinical Global Impressions Scale (CGI) assessed by the physician</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in neuropsychological outcomes</measure>
    <time_frame>At baseline and at 6 months</time_frame>
    <description>Differences between groups measured by Scores of the Conners Continuous Performance Test-II (CPT-II) which evaluate potential problems related to executive functions perception, internal ordering, working memory, motor control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in emotional outcomes</measure>
    <time_frame>At baseline and at 6 months</time_frame>
    <description>Differences between groups measured by Cognitive Assessment System (CAS) for children between 6-8 years old and by State-Trait Anxiety Inventory for Children (STAIC) for children between 9-12 years old.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Children's Quality of Life</measure>
    <time_frame>At baseline and at 6 months</time_frame>
    <description>Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life of Parents of Children with ADHD</measure>
    <time_frame>At baseline and at 6 months</time_frame>
    <description>Differences between groups measured with a Short Version of the World Health Organization Quality of Life Instruments (WHOQoL)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in nutritional status</measure>
    <time_frame>At baseline and at 2, 4 and 6 months</time_frame>
    <description>Differences between groups measured by anthropometry and feeding scale of the Health National Survey (National Statistical Institute, Spain).</description>
  </other_outcome>
  <other_outcome>
    <measure>Tolerability of study product</measure>
    <time_frame>At 2, 4 and 6 months</time_frame>
    <description>Differences between groups measured by product acceptability.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">231</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder (ADHD)</condition>
  <arm_group>
    <arm_group_label>Medium Chain Triglycerides Supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Medium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omega-3 Fatty Acids Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Omega-3 Fatty Acid supplement provides 540 mg of eicosapentaenoic acid (EPA), 340 mg of docosahexaenoic acid (DHA), 60 mg of gamma linolenic acid (GLA/Omega-6), 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 Fatty Acids</intervention_name>
    <description>Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.</description>
    <arm_group_label>Omega-3 Fatty Acids Supplement</arm_group_label>
    <other_name>EPA/DHA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Medium Chain Triglycerides</intervention_name>
    <description>Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.</description>
    <arm_group_label>Medium Chain Triglycerides Supplement</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 6 and 11 years 11 months.&#xD;
&#xD;
          -  ADHD diagnosis according to DSM-IV-TR criteria&#xD;
&#xD;
          -  Children whose parents are able to reliably meet all visits and all the tests required&#xD;
             for this study based on the researcher judgment&#xD;
&#xD;
          -  Patient representative (either parents or legal guardians) must understand the&#xD;
             conditions of the study and sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not meet diagnostic criteria for ADHD&#xD;
&#xD;
          -  Patients with a previously known allergy or intolerance to the components of Omega- 3&#xD;
             supplement&#xD;
&#xD;
          -  Patients with underlying diseases that, according to medical criteria , are not&#xD;
             eligible for supplementation with Omega-3 fatty acids : fatty liver disease (or other&#xD;
             liver disease), bleeding disorders and cardiovascular disease&#xD;
&#xD;
          -  Patients with allergies to fish and /or shellfish&#xD;
&#xD;
          -  Patients who have received ADHD pharmacological treatment or fatty acid supplements at&#xD;
             any dose for more than 7 consecutive days within the last 3 months&#xD;
&#xD;
          -  Patients who have received psychological or psycho-educational treatment in the past 3&#xD;
             months&#xD;
&#xD;
          -  Patients who have had some kind of psychometric diagnostic tests in the last year&#xD;
&#xD;
          -  Patients with scores corresponding to a lower mental age (more than 1 year less)&#xD;
             according to the Wechsler Intelligence Cubes Scale for Children (WISC-IV)&#xD;
&#xD;
          -  Patients with severe emotional problems according to the CAS or STAIC tests&#xD;
&#xD;
          -  Patients participating in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jordi Sasot Llevadot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Médico Teknon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana Bielsa, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Unidad Clínica Familianova Schola</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miquel Sisteré, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre de Salut Mental Infanto-Juvenil, Lleida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Esther Cardo Jalón, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Unidad Pediártica Balear, Palma de Mallorca</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabel Hernández Otero, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario Virgen de la Victoria, Málaga.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Médico Teknon</name>
      <address>
        <city>Barcelona</city>
        <zip>08017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://congresoaep2015.pulsointeractivo.com/readcontents.php?file=webstructure/06_pos.sin_defensa-def.pdf</url>
    <description>Spanish Pediatric Association (AEP) Congress 2015 - Poster Book - pg.287</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Omega-3</keyword>
  <keyword>ADHD</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Inattention</keyword>
  <keyword>Hyperactivity</keyword>
  <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>
  </condition_browse>
  <!-- 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/NCT02248948
org study id: ECOMEGA-TDAH-014
secondary id: 2013-004638-14
nct id: NCT02248948
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the
      Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind
      study to evaluate the effect of an Omega-3 Fatty Acid Supplement with EPA, DHA, vitamins E
      and D on ADHD clinical symptoms (according to Diagnostic and Statistical Manual for Mental
      Disorders, 4th. edition (DSM-IV-TR) criteria) in children between 6 and 11 years. Patients
      will be randomized to receive either the new omega-3 supplement or a placebo during 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Improvement in clinical symptoms of ADHD
time frame: At baseline and at 6 months
description: Differences between groups measured by:
Number of criteria of the ADHD-Scale-IV rated by parents and teachers
Clinical Global Impressions Scale (CGI) assessed by the physician
measure: Changes in neuropsychological outcomes
time frame: At baseline and at 6 months
description: Differences between groups measured by Scores of the Conners Continuous Performance Test-II (CPT-II) which evaluate potential problems related to executive functions perception, internal ordering, working memory, motor control.
measure: Changes in emotional outcomes
time frame: At baseline and at 6 months
description: Differences between groups measured by Cognitive Assessment System (CAS) for children between 6-8 years old and by State-Trait Anxiety Inventory for Children (STAIC) for children between 9-12 years old.
measure: Changes in Children's Quality of Life
time frame: At baseline and at 6 months
description: Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)
measure: Changes in Quality of Life of Parents of Children with ADHD
time frame: At baseline and at 6 months
description: Differences between groups measured with a Short Version of the World Health Organization Quality of Life Instruments (WHOQoL)
measure: Changes in nutritional status
time frame: At baseline and at 2, 4 and 6 months
description: Differences between groups measured by anthropometry and feeding scale of the Health National Survey (National Statistical Institute, Spain).
measure: Tolerability of study product
time frame: At 2, 4 and 6 months
description: Differences between groups measured by product acceptability.
arm group label: Medium Chain Triglycerides Supplement
arm group type: Placebo Comparator
description: Medium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.
arm group label: Omega-3 Fatty Acids Supplement
arm group type: Experimental
description: The Omega-3 Fatty Acid supplement provides 540 mg of eicosapentaenoic acid (EPA), 340 mg of docosahexaenoic acid (DHA), 60 mg of gamma linolenic acid (GLA/Omega-6), 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.
intervention type: Dietary Supplement
intervention name: Omega-3 Fatty Acids
description: Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.
arm group label: Omega-3 Fatty Acids Supplement
other name: EPA/DHA
intervention type: Dietary Supplement
intervention name: Medium Chain Triglycerides
description: Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.
arm group label: Medium Chain Triglycerides Supplement
other name: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
last name: Jordi Sasot Llevadot, MD
role: Principal Investigator
affiliation: Centro Médico Teknon
last name: Ana Bielsa, MD
role: Study Chair
affiliation: Unidad Clínica Familianova Schola
last name: Miquel Sisteré, MD
role: Study Chair
affiliation: Centre de Salut Mental Infanto-Juvenil, Lleida
last name: Esther Cardo Jalón, MD
role: Study Chair
affiliation: Unidad Pediártica Balear, Palma de Mallorca
last name: Isabel Hernández Otero, MD
role: Study Chair
affiliation: Hospital Universitario Virgen de la Victoria, Málaga.
facility: 
country: Spain
url: http://congresoaep2015.pulsointeractivo.com/readcontents.php?file=webstructure/06_pos.sin_defensa-def.pdf
description: Spanish Pediatric Association (AEP) Congress 2015 - Poster Book - pg.287
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity