<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/NCT01699386</url>
  </required_header>
  <id_info>
    <org_study_id>AH73</org_study_id>
    <nct_id>NCT01699386</nct_id>
  </id_info>
  <brief_title>Growth of Infants Fed an Elemental Medical Food</brief_title>
  <official_title>Growth of Infants Fed an Elemental Medical Food</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>
      Effects on weight will be monitored in healthy infant subjects consuming assigned infant&#xD;
      formulas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1999</start_date>
  <completion_date type="Actual">December 2000</completion_date>
  <primary_completion_date type="Actual">December 2000</primary_completion_date>
  <phase>Phase 3</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>Weight</measure>
    <time_frame>14 days of age to 112 days of age</time_frame>
    <description>weight gain during the study period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anthropometric Measurements</measure>
    <time_frame>14 days of age to 112 days of age</time_frame>
    <description>length, head circumference, and length gain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GI Tolerance</measure>
    <time_frame>At visits 14 and 28</time_frame>
    <description>daily stool number, stool consistency, formula intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lab Measurement</measure>
    <time_frame>At 112 day visit</time_frame>
    <description>serum albumin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Healthy Infants</condition>
  <arm_group>
    <arm_group_label>Control Study Formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>protein hydrolysate formula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Study Formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>free-amino acid-based medical food</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Study Formula</intervention_name>
    <description>feed as lib</description>
    <arm_group_label>Control Study Formula</arm_group_label>
    <other_name>protein hydrolysate formula</other_name>
    <other_name>Nutramigen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Study Formula</intervention_name>
    <description>feed as lib</description>
    <arm_group_label>Experimental Study Formula</arm_group_label>
    <other_name>free-amino acid-based medical food</other_name>
    <other_name>EleCare</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton, healthy infant&#xD;
&#xD;
          -  Gestational age of 37 to 42 weeks&#xD;
&#xD;
          -  Birth weight of 2500 grams or greater&#xD;
&#xD;
          -  Age between birth and 9 days of age&#xD;
&#xD;
          -  Parents agree to not administer mineral or vitamin supplements during the study period&#xD;
&#xD;
          -  Parents agree to feed study formula exclusively for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maternal, fetal or perinatal history which may have adverse effects on growth&#xD;
&#xD;
          -  Multiple birth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>9 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marlene W Borschel, PhD, RD</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>T&amp;W Research</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242-1083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</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/NCT01699386
org study id: AH73
nct id: NCT01699386
lead sponsor: 
has dmc: No
Effects on weight will be monitored in healthy infant subjects consuming assigned infant
      formulas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Weight
time frame: 14 days of age to 112 days of age
description: weight gain during the study period
measure: Anthropometric Measurements
time frame: 14 days of age to 112 days of age
description: length, head circumference, and length gain
measure: GI Tolerance
time frame: At visits 14 and 28
description: daily stool number, stool consistency, formula intake
measure: Lab Measurement
time frame: At 112 day visit
description: serum albumin
arm group label: Control Study Formula
arm group type: Active Comparator
description: protein hydrolysate formula
arm group label: Experimental Study Formula
arm group type: Experimental
description: free-amino acid-based medical food
intervention type: Other
intervention name: Control Study Formula
description: feed as lib
arm group label: Control Study Formula
other name: protein hydrolysate formula
other name: Nutramigen
intervention type: Other
intervention name: Experimental Study Formula
description: feed as lib
arm group label: Experimental Study Formula
other name: free-amino acid-based medical food
other name: EleCare
criteria: 
gender: All
minimum age: N/A
maximum age: 9 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Marlene W Borschel, PhD, RD
role: Study Chair
affiliation: Abbott Nutrition
facility: 
facility: 
country: United States
responsible party type: Sponsor