<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/NCT03014115</url>
  </required_header>
  <id_info>
    <org_study_id>2015-1080</org_study_id>
    <nct_id>NCT03014115</nct_id>
  </id_info>
  <brief_title>Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants</brief_title>
  <official_title>EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DSM Nutritional Products, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SynteractHCR</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>DSM Nutritional Products, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in&#xD;
      infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6&#xD;
      months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates,&#xD;
      immune markers) and safety information in these 12-18 month old infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76%&#xD;
      ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6&#xD;
      months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference&#xD;
      in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation&#xD;
      will be measured. Parents will be asked about the infant's current daily diet (fatty acid&#xD;
      intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6&#xD;
      month extension period (non-supplemented) to collect additional measures of efficacy (i.e.&#xD;
      infections and illnesses, immune markers) and safety out to 18 months of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>total plasma fatty acid ARA levels</measure>
    <time_frame>6 months of supplementation</time_frame>
    <description>difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of infections</measure>
    <time_frame>6 months of supplementation</time_frame>
    <description>record number, type and duration of infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight gain</measure>
    <time_frame>6 months of supplementation</time_frame>
    <description>differences between groups in weight gain (kg/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length gain</measure>
    <time_frame>6 months of supplementation</time_frame>
    <description>differences between groups in length gain (cm/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>head circumference</measure>
    <time_frame>6 months of supplementation</time_frame>
    <description>differences between groups in head circumference (cm/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dietary intake of ARA</measure>
    <time_frame>6 months of supplementation</time_frame>
    <description>24 hour recall questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma levels of immune markers</measure>
    <time_frame>6 months of supplementation</time_frame>
    <description>cytokines and T cells levels in plasma will be measured</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Healthy Infants</condition>
  <arm_group>
    <arm_group_label>combination ARA+ DHA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>combination 0.76% ARA+ 0.4% DHA in infant formula per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DHA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0% ARA +0.4% DHA in infant formula per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>combination ARA + DHA</intervention_name>
    <description>combination ARA + DHA supplemented infant formula</description>
    <arm_group_label>combination ARA+ DHA</arm_group_label>
    <other_name>infant formula</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>DHA</intervention_name>
    <description>DHA supplemented infant formula</description>
    <arm_group_label>DHA</arm_group_label>
    <other_name>infant formula</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton infants,&#xD;
&#xD;
          -  parent of legal age to consent,&#xD;
&#xD;
          -  willing to feed the child the assigned study formula for the treatment duration,&#xD;
&#xD;
          -  parent agrees to scheduled blood draws&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  exclusively breastfed or formula-fed beyond 6 months,&#xD;
&#xD;
          -  difficulty swallowing or other congenital malformation or metabolic anomaly,&#xD;
&#xD;
          -  taking omega-3 (supplemented) foods,&#xD;
&#xD;
          -  mother had gestational diabetes or is Type II diabetic,&#xD;
&#xD;
          -  born at &lt;37 weeks gestational age,&#xD;
&#xD;
          -  participating in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Weeks</minimum_age>
    <maximum_age>26 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ascension Marcos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Ciencia y Tecnología de Alimentos y Nutrición</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Salud Aravaca</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Salud Arganda del Rey</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>arachidonic</keyword>
  <keyword>docosahexaenoic acid</keyword>
  <keyword>infant formula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</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/NCT03014115
org study id: 2015-1080
nct id: NCT03014115
lead sponsor: 
collaborator: 
has dmc: No
The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in
      infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6
      months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates,
      immune markers) and safety information in these 12-18 month old infants.
This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76%
      ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6
      months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference
      in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
      will be measured. Parents will be asked about the infant's current daily diet (fatty acid
      intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6
      month extension period (non-supplemented) to collect additional measures of efficacy (i.e.
      infections and illnesses, immune markers) and safety out to 18 months of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: total plasma fatty acid ARA levels
time frame: 6 months of supplementation
description: difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
measure: incidence of infections
time frame: 6 months of supplementation
description: record number, type and duration of infections
measure: weight gain
time frame: 6 months of supplementation
description: differences between groups in weight gain (kg/d)
measure: length gain
time frame: 6 months of supplementation
description: differences between groups in length gain (cm/d)
measure: head circumference
time frame: 6 months of supplementation
description: differences between groups in head circumference (cm/d)
measure: dietary intake of ARA
time frame: 6 months of supplementation
description: 24 hour recall questionnaire
measure: plasma levels of immune markers
time frame: 6 months of supplementation
description: cytokines and T cells levels in plasma will be measured
arm group label: combination ARA+ DHA
arm group type: Active Comparator
description: combination 0.76% ARA+ 0.4% DHA in infant formula per day
arm group label: DHA
arm group type: Experimental
description: 0% ARA +0.4% DHA in infant formula per day
intervention type: Dietary Supplement
intervention name: combination ARA + DHA
description: combination ARA + DHA supplemented infant formula
arm group label: combination ARA+ DHA
other name: infant formula
intervention type: Dietary Supplement
intervention name: DHA
description: DHA supplemented infant formula
arm group label: DHA
other name: infant formula
criteria: 
gender: All
minimum age: 22 Weeks
maximum age: 26 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Ascension Marcos, PhD
role: Principal Investigator
affiliation: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Infections
sharing ipd: No