<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/NCT01698840</url>
  </required_header>
  <id_info>
    <org_study_id>H-31433</org_study_id>
    <nct_id>NCT01698840</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D in Diets of Preterm Infants</brief_title>
  <official_title>An Evaluation of the Effects of Two Levels of Vitamin D in Infants Fed Preterm or Transitional Formula on Serum 25-Hydroxyvitamin D and Bone Status in Preterm Infants: A Double-Blind, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mead Johnson Nutrition</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Children's Nutrition Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation&#xD;
      at birth. However, few data are available related to follow-up of infants receiving these&#xD;
      formulas who were 28-34 weeks gestation at birth.&#xD;
&#xD;
      Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead&#xD;
      to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less&#xD;
      than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2023</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age</measure>
    <time_frame>Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age</measure>
    <time_frame>Last 7 days of hospitalization and at 52 weeks PMA</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Premature Infants</condition>
  <arm_group>
    <arm_group_label>Investigational Nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Investigational Nutrition group will receive vitamin D drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Nutrition</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Routine Nutrition group will receive placebo drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <arm_group_label>Investigational Nutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Routine Nutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born at 28 0/7 to 34 6/7 weeks PMA and 1000-2250 g birth weight.&#xD;
&#xD;
          -  Currently 34 0/7 to 38 6/7 weeks post-menstrual age at time of consent.&#xD;
&#xD;
          -  Born at Texas Children's (including Pavilion for Women) or Methodist campus hospitals&#xD;
             or transferred within 48 hours of birth.&#xD;
&#xD;
          -  Care expected to be provided at one of these institutions until discharge home.&#xD;
&#xD;
          -  Any initial feeding will be permitted, but expected to transition to primarily (80% of&#xD;
             feeds or up to 2 breast milk feeds per day) infant formula by 38 6/7 weeks PMA or&#xD;
             hospital discharge, whichever comes first.&#xD;
&#xD;
          -  Able to tolerate 22 kcal/oz transitional formula and receive a volume of at least 130&#xD;
             mL/kg/day total feeding volume.&#xD;
&#xD;
          -  No longer receiving any form of mechanical ventilation or diuretics. Low flow nasal&#xD;
             cannula (&lt; ¼ LPM) will be permitted if it is anticipated this will be discontinued&#xD;
             before hospital discharge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bronchopulmonary dysplasia (BPD) requiring daily use of diuretics beyond 38 6/7 weeks&#xD;
             PMA (or hospital discharge, whichever comes first) and &gt; 22 kcal/oz concentration&#xD;
             formula beyond 38 6/7 weeks PMA.&#xD;
&#xD;
          -  Major congenital anomalies, history of proven Stage 2 or above NEC, or severe feeding&#xD;
             intolerance.&#xD;
&#xD;
          -  Caloric density greater than 22 kcal/oz.&#xD;
&#xD;
          -  Higher order multiples (However, twins are acceptable. Twins will be randomized&#xD;
             together. Only data from 1 twin picked at random will be used in the final analyses.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy h, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor College of Medicine / Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Amy Hair</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Transitional Formula</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_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/NCT01698840
org study id: H-31433
nct id: NCT01698840
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation
      at birth. However, few data are available related to follow-up of infants receiving these
      formulas who were 28-34 weeks gestation at birth.

      Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead
      to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less
      than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age
time frame: Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA)
measure: Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age
time frame: Last 7 days of hospitalization and at 52 weeks PMA
arm group label: Investigational Nutrition
arm group type: Experimental
description: Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Investigational Nutrition group will receive vitamin D drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
arm group label: Routine Nutrition
arm group type: Placebo Comparator
description: Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Routine Nutrition group will receive placebo drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
intervention type: Dietary Supplement
intervention name: Vitamin D
arm group label: Investigational Nutrition
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Routine Nutrition
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amy h, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Amy Hair
investigator title: Assistant Professor
mesh term: Vitamin D