<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/NCT03035721</url>
  </required_header>
  <id_info>
    <org_study_id>Low protein formula_RCT</org_study_id>
    <nct_id>NCT03035721</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT</brief_title>
  <official_title>Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Humana Co.Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy&#xD;
      full-term infants by investigating effects on growth and gastrointestinal tolerance and by&#xD;
      identifying any adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infants were randomized to receive either a standard protein formula or a low-protein&#xD;
      formula. The composition of the low-protein formula vs the standard formula was: energy (65&#xD;
      vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).&#xD;
&#xD;
      To investigate the safety of the low-protein formula without any bias, a 4-month intervention&#xD;
      period was selected during which the infants were fed only formula.&#xD;
&#xD;
      Anthropometric parameters (weight, length, and head circumference) and body composition were&#xD;
      assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the&#xD;
      occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two&#xD;
      weeks either by clinic visits or phone calls.&#xD;
&#xD;
      The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term&#xD;
      infants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">January 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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Anthropometric and body composition measurements were performed by three medical investigators who were blinded to allocated treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate weight</measure>
    <time_frame>enrollment, 2 months and 4 months</time_frame>
    <description>Weight (g) of each baby was measured on an electronic scale accurate to 0.1 g (PEA POD Infant Body Composition System; Cosmed, Concord, CA, US). Body length was measured to the nearest 1 mm on a Harpenden neonatometer (Holtain, Crymych, UK).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate lenght</measure>
    <time_frame>enrollment 2 months and 4 months</time_frame>
    <description>Lenght (cm) of each baby was measured according standard procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate head circumference</measure>
    <time_frame>enrollment 2 months and 4 months</time_frame>
    <description>Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate body composition (fat mass and fat free mass)</measure>
    <time_frame>enrollment, 2 months and 4 months</time_frame>
    <description>Body composition [fat mass and fat free mass (g)]was assessed using an air-displacement plethysmography (PEA POD Infant Body Composition System; COSMED, Italy).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate weight increase</measure>
    <time_frame>2 months, 4 months</time_frame>
    <description>Weight increase (g/day) was calculated as a change in body weight from weight at study enrollment divided by the time interval from enrolment to the assessment at 4 months Fat mass (g/day) and fat free mass (g/day) increases were also calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate gastrointestinal tolerance</measure>
    <time_frame>2 months and 4 months</time_frame>
    <description>Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.&#xD;
The occurrence of spitting up, vomiting and colic, defined as intermittent attacks of abdominal pain when the baby screamed and drew up his/her legs but was well between episodes, was recorded. Colic was further classified as severe if the episodes were more than twice per day. Daily frequency of stool passage was also collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate occurence of adverse events</measure>
    <time_frame>2 months and 4 months</time_frame>
    <description>Adverse events were assessed based on inquires to the parents and on their daily records.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate body mass index (k/m2: weight/length2)</measure>
    <time_frame>enrollment, 2 months and 4 months</time_frame>
    <description>Body mass index [BMI: (Kg/m2)] was assessed for all infants enrolled at each study points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate z-score</measure>
    <time_frame>enrollment, 2 months and 4 months</time_frame>
    <description>Z-scores values for age were then calculated using the z score calculator provided by WHO [WHO Anthro (version 3.2.2, January 2011)].</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Safety Issues</condition>
  <condition>Infant Nutrition Disorders</condition>
  <arm_group>
    <arm_group_label>Low protein formula group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Full term healthy infants randomized to receive a low protein formula for the first 4 months of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard protein formula group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breastfeeding group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Breastfed full term healthy infants</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low protein formula</intervention_name>
    <description>Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.</description>
    <arm_group_label>Low protein formula group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Standard protein formula</intervention_name>
    <description>Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.</description>
    <arm_group_label>Standard protein formula group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  singleton&#xD;
&#xD;
          -  full-term infants (gestational age 37/0 to 41/6 weeks)&#xD;
&#xD;
          -  birth weight adequate for gestational age (&gt;p10 and &lt;p90 for gestational age)&#xD;
             according to the World Health Organization growth charts.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of congenital diseases&#xD;
&#xD;
          -  presence of chromosomal abnormalities&#xD;
&#xD;
          -  presence of conditions that could interfere with growth, such as brain, metabolic,&#xD;
             cardiac and gastrointestinal diseases, perinatal infections.&#xD;
&#xD;
          -  being born to mother affected by endocrine and/or metabolic diseases&#xD;
&#xD;
          -  having a family history of allergic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>3 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paola Roggero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>June 28, 2017</last_update_submitted>
  <last_update_submitted_qc>June 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Full term healthy infants</keyword>
  <keyword>Low protein content formula</keyword>
  <keyword>Safety</keyword>
  <keyword>Growth</keyword>
  <keyword>Body composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Infant Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03035721
org study id: Low protein formula_RCT
nct id: NCT03035721
lead sponsor: 
collaborator: 
has dmc: No
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy
      full-term infants by investigating effects on growth and gastrointestinal tolerance and by
      identifying any adverse effects.
Infants were randomized to receive either a standard protein formula or a low-protein
      formula. The composition of the low-protein formula vs the standard formula was: energy (65
      vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).

      To investigate the safety of the low-protein formula without any bias, a 4-month intervention
      period was selected during which the infants were fed only formula.

      Anthropometric parameters (weight, length, and head circumference) and body composition were
      assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the
      occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two
      weeks either by clinic visits or phone calls.

      The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term
      infants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Anthropometric and body composition measurements were performed by three medical investigators who were blinded to allocated treatment.
measure: Evaluate weight
time frame: enrollment, 2 months and 4 months
description: Weight (g) of each baby was measured on an electronic scale accurate to 0.1 g (PEA POD Infant Body Composition System; Cosmed, Concord, CA, US). Body length was measured to the nearest 1 mm on a Harpenden neonatometer (Holtain, Crymych, UK).
measure: Evaluate lenght
time frame: enrollment 2 months and 4 months
description: Lenght (cm) of each baby was measured according standard procedures.
measure: Evaluate head circumference
time frame: enrollment 2 months and 4 months
description: Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.
measure: Evaluate body composition (fat mass and fat free mass)
time frame: enrollment, 2 months and 4 months
description: Body composition [fat mass and fat free mass (g)]was assessed using an air-displacement plethysmography (PEA POD Infant Body Composition System; COSMED, Italy).
measure: Evaluate weight increase
time frame: 2 months, 4 months
description: Weight increase (g/day) was calculated as a change in body weight from weight at study enrollment divided by the time interval from enrolment to the assessment at 4 months Fat mass (g/day) and fat free mass (g/day) increases were also calculated.
measure: Evaluate gastrointestinal tolerance
time frame: 2 months and 4 months
description: Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.
The occurrence of spitting up, vomiting and colic, defined as intermittent attacks of abdominal pain when the baby screamed and drew up his/her legs but was well between episodes, was recorded. Colic was further classified as severe if the episodes were more than twice per day. Daily frequency of stool passage was also collected.
measure: Evaluate occurence of adverse events
time frame: 2 months and 4 months
description: Adverse events were assessed based on inquires to the parents and on their daily records.
measure: Evaluate body mass index (k/m2: weight/length2)
time frame: enrollment, 2 months and 4 months
description: Body mass index [BMI: (Kg/m2)] was assessed for all infants enrolled at each study points.
measure: Evaluate z-score
time frame: enrollment, 2 months and 4 months
description: Z-scores values for age were then calculated using the z score calculator provided by WHO [WHO Anthro (version 3.2.2, January 2011)].
arm group label: Low protein formula group
arm group type: Experimental
description: Full term healthy infants randomized to receive a low protein formula for the first 4 months of life
arm group label: Standard protein formula group
arm group type: Active Comparator
description: Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life
arm group label: Breastfeeding group
arm group type: No Intervention
description: Breastfed full term healthy infants
intervention type: Dietary Supplement
intervention name: Low protein formula
description: Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.
arm group label: Low protein formula group
intervention type: Dietary Supplement
intervention name: Standard protein formula
description: Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.
arm group label: Standard protein formula group
criteria: 
gender: All
minimum age: 1 Day
maximum age: 3 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Paola Roggero, MD
role: Principal Investigator
affiliation: NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Nutrition Disorders
mesh term: Infant Nutrition Disorders
sharing ipd: Undecided