<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/NCT01669655</url>
  </required_header>
  <id_info>
    <org_study_id>AK99</org_study_id>
    <nct_id>NCT01669655</nct_id>
  </id_info>
  <brief_title>Plasma Profile of Exclusively Breastfed Infants</brief_title>
  <official_title>Plasma Profile of Exclusively Breastfed Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Nutrition</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To characterize nutrient levels in breastfeeding infants and their mothers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are (1) to characterize plasma lutein levels in breastfed&#xD;
      infants in an Asian population where lactating mothers have diets habitually high in lutein&#xD;
      and (2) investigate how blood lutein levels in breastfed infants vary according to lutein&#xD;
      content of the mothers' milk in such a population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma carotenoids in breastfed infants</measure>
    <time_frame>At visit 1 (enrollment)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma carotenoids in mothers of breastfed infants</measure>
    <time_frame>At visit 1 (enrollment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary carotenoid intake of mothers of breastfed infants</measure>
    <time_frame>At visit 1 (enrollment) and visit 2 (14 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carotenoid levels in breastmilk</measure>
    <time_frame>At visit 1 (enrollment) and visit 2 (14 days)</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">56</enrollment>
  <condition>Breast Fed Infants</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood sample; Human Milk sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Breastfeeding infants and their mothers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant is judged to be in good health.&#xD;
&#xD;
          -  Infant is a singleton from a full term birth.&#xD;
&#xD;
          -  Infant's birth weight was &gt; 2490 g.&#xD;
&#xD;
          -  Infant is between 6 weeks and 16 weeks (42 to 112 days).&#xD;
&#xD;
          -  Infant must have been exclusively breastfed at enrollment.&#xD;
&#xD;
          -  Mother's intake indicates a consumption of an average of at least three servings of&#xD;
             fruit and/or vegetables per day.&#xD;
&#xD;
          -  Mother is a non-smoker.&#xD;
&#xD;
          -  Mother is in good health.&#xD;
&#xD;
          -  Mother confirms her intention to continue breastfeeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An adverse maternal, fetal or infant medical history that is thought to have potential&#xD;
             for effects on growth, and/or development.&#xD;
&#xD;
          -  Infants who have consumed medications or herbal preparations during past 14 days prior&#xD;
             to enrollment.&#xD;
&#xD;
          -  Infants who have consumed any solid or liquid foods or juices prior to enrollment.&#xD;
&#xD;
          -  Infants who have received any supplements containing carotenoids prior to enrollment.&#xD;
&#xD;
          -  Mother who is consuming dietary supplements containing carotenoids.&#xD;
&#xD;
          -  Participation in another study that has not been approved as a concomitant study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>16 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xianfeng Zhao, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition, R&amp;D China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fudan University of Shanghai</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>January 19, 2015</last_update_submitted>
  <last_update_submitted_qc>January 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01669655
org study id: AK99
nct id: NCT01669655
lead sponsor: 
has dmc: No
To characterize nutrient levels in breastfeeding infants and their mothers.
The objectives of this study are (1) to characterize plasma lutein levels in breastfed
      infants in an Asian population where lactating mothers have diets habitually high in lutein
      and (2) investigate how blood lutein levels in breastfed infants vary according to lutein
      content of the mothers' milk in such a population.
observational model: Family-Based
time perspective: Prospective
measure: Plasma carotenoids in breastfed infants
time frame: At visit 1 (enrollment)
measure: Plasma carotenoids in mothers of breastfed infants
time frame: At visit 1 (enrollment)
measure: Dietary carotenoid intake of mothers of breastfed infants
time frame: At visit 1 (enrollment) and visit 2 (14 days)
measure: Carotenoid levels in breastmilk
time frame: At visit 1 (enrollment) and visit 2 (14 days)
Blood sample; Human Milk sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 16 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Xianfeng Zhao, MD, PhD
role: Study Chair
affiliation: Abbott Nutrition, R&D China
facility: 
country: China
responsible party type: Sponsor