<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/NCT03770845</url>
  </required_header>
  <id_info>
    <org_study_id>NUTRIPF</org_study_id>
    <nct_id>NCT03770845</nct_id>
  </id_info>
  <brief_title>Nutritional Assessment in Idiopathic Pulmonary Fibrosis</brief_title>
  <acronym>NUTRIPF</acronym>
  <official_title>Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Gerardo Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Gerardo Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In recent years nutritional status assumed increasing importance in the evaluation of chronic&#xD;
      respiratory diseases, considering that their clinical course is often characterized by a&#xD;
      progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary&#xD;
      Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of&#xD;
      patients, nor the impact of the introduction of specific anti-fibrotic agents on the&#xD;
      nutritional status of these patients.&#xD;
&#xD;
      Aim of this study is to assess the nutritional status of patients with IPF at the time of&#xD;
      diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or&#xD;
      nintedanib, on the nutritional status itself.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preliminary studies on Idiopathic Pulmonary Fibrosis (IPF) seem to suggest that nutritional&#xD;
      status has an impact on clinical outcomes, as already demonstrated in COPD. However, few data&#xD;
      regarding this subject are available for patients with IPF.&#xD;
&#xD;
      Primary aim of this study is to assess the nutritional status of patients diagnosed with mild&#xD;
      to moderate IPF at the time of disease diagnosis. To do so, the investigators assess the&#xD;
      prevalence of nutritional disorders at baseline through nutritional scores evaluated with&#xD;
      specific questionnaires and through the identification of the following metabolic phenotypes&#xD;
      (based on those previously applied in COPD): cachexia, sarcopenia, normal nutritional status,&#xD;
      obesity, sarcopenic obesity.&#xD;
&#xD;
      Secondary aims of this study are:&#xD;
&#xD;
        -  the evaluation of the impact of the introduction of an anti-fibrotic pharmacological&#xD;
           agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of&#xD;
           metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation&#xD;
           of antifibrotic therapy.&#xD;
&#xD;
        -  the assessment of calcium and vitamin D metabolism, by blood sampling, in patients&#xD;
           diagnosed with mild to moderate IPF at the time of disease diagnosis and at 6 months&#xD;
           from the initiation of antifibrotic therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>BMI (body mass index)</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FFMI (fat free mass index)</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SMI (skeletal muscle mass index)</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BFMI (body fat mass index)</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Grip</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdominal circumference</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini Nutritional Assessment (MNA)</measure>
    <time_frame>baseline (IPF diagnosis)</time_frame>
    <description>questionnaire score (maximum score 30): total score &gt; 23.5 = normal nutritional status; total score &lt; 23.5 = inadequate nutritional status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI (body mass index)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FFMI (fat free mass index)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SMI (skeletal muscle mass index)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BFMI (body fat mass index)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand Grip</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal circumference</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Malnutrition Universal Screening Tool (MUST)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini Nutritional Assessment (MNA)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>questionnaire score (maximum score 30): total score &gt; 23.5 = normal nutritional status; total score &lt; 23.5 = inadequate nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma calcium</measure>
    <time_frame>baseline (IPF diagnosis) and 6 months after baseline</time_frame>
    <description>calcium level in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma vitamin D</measure>
    <time_frame>baseline (IPF diagnosis) and 6 months after baseline</time_frame>
    <description>vitamin D level in plasma</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age greater than or equal to 18 years;&#xD;
&#xD;
          -  diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary&#xD;
             discussion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml /&#xD;
             min;&#xD;
&#xD;
          -  NYHA class IV;&#xD;
&#xD;
          -  severe liver failure, defined as Child-Pugh score class C;&#xD;
&#xD;
          -  active solid or haematological neoplasms;&#xD;
&#xD;
          -  having already received (currently or in the past) therapy with pirfenidone or&#xD;
             nintedanib;&#xD;
&#xD;
          -  inability to walk without help;&#xD;
&#xD;
          -  need for oxygen therapy at rest;&#xD;
&#xD;
          -  participation in other interventional experimental protocols with use of a medicinal&#xD;
             product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>INRCA Casatenovo</name>
      <address>
        <city>Casatenovo</city>
        <state>Lecco</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Gerardo Hospital</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G. Salvini Hospital</name>
      <address>
        <city>Garbagnate Milanese</city>
        <state>Milano</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Circolo</name>
      <address>
        <city>Busto Arsizio</city>
        <state>Varese</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale SS. Annunziata</name>
      <address>
        <city>Chieti</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Martino Hospital</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Giuseppe Hospital</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Paolo and San Carlo Hospital</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore Novara</name>
      <address>
        <city>Novara</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Gerardo Hospital</investigator_affiliation>
    <investigator_full_name>Paola Faverio</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>nutritional status</keyword>
  <keyword>vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT03770845
org study id: NUTRIPF
nct id: NCT03770845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In recent years nutritional status assumed increasing importance in the evaluation of chronic
      respiratory diseases, considering that their clinical course is often characterized by a
      progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary
      Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of
      patients, nor the impact of the introduction of specific anti-fibrotic agents on the
      nutritional status of these patients.

      Aim of this study is to assess the nutritional status of patients with IPF at the time of
      diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or
      nintedanib, on the nutritional status itself.
Preliminary studies on Idiopathic Pulmonary Fibrosis (IPF) seem to suggest that nutritional
      status has an impact on clinical outcomes, as already demonstrated in COPD. However, few data
      regarding this subject are available for patients with IPF.

      Primary aim of this study is to assess the nutritional status of patients diagnosed with mild
      to moderate IPF at the time of disease diagnosis. To do so, the investigators assess the
      prevalence of nutritional disorders at baseline through nutritional scores evaluated with
      specific questionnaires and through the identification of the following metabolic phenotypes
      (based on those previously applied in COPD): cachexia, sarcopenia, normal nutritional status,
      obesity, sarcopenic obesity.

      Secondary aims of this study are:

        -  the evaluation of the impact of the introduction of an anti-fibrotic pharmacological
           agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of
           metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation
           of antifibrotic therapy.

        -  the assessment of calcium and vitamin D metabolism, by blood sampling, in patients
           diagnosed with mild to moderate IPF at the time of disease diagnosis and at 6 months
           from the initiation of antifibrotic therapy.
observational model: Cohort
time perspective: Prospective
measure: BMI (body mass index)
time frame: baseline (IPF diagnosis)
description: kg/m2
measure: FFMI (fat free mass index)
time frame: baseline (IPF diagnosis)
description: kg/m2
measure: SMI (skeletal muscle mass index)
time frame: baseline (IPF diagnosis)
description: kg/m2
measure: BFMI (body fat mass index)
time frame: baseline (IPF diagnosis)
description: kg/m2
measure: Hand Grip
time frame: baseline (IPF diagnosis)
description: kg
measure: Abdominal circumference
time frame: baseline (IPF diagnosis)
description: cm
measure: Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)
time frame: baseline (IPF diagnosis)
description: questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
measure: Mini Nutritional Assessment (MNA)
time frame: baseline (IPF diagnosis)
description: questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
measure: BMI (body mass index)
time frame: 6 months after baseline
description: kg/m2
measure: FFMI (fat free mass index)
time frame: 6 months after baseline
description: kg/m2
measure: SMI (skeletal muscle mass index)
time frame: 6 months after baseline
description: kg/m2
measure: BFMI (body fat mass index)
time frame: 6 months after baseline
description: kg/m2
measure: Hand Grip
time frame: 6 months after baseline
description: kg
measure: Abdominal circumference
time frame: 6 months after baseline
description: cm
measure: Malnutrition Universal Screening Tool (MUST)
time frame: 6 months after baseline
description: questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
measure: Mini Nutritional Assessment (MNA)
time frame: 6 months after baseline
description: questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
measure: plasma calcium
time frame: baseline (IPF diagnosis) and 6 months after baseline
description: calcium level in plasma
measure: plasma vitamin D
time frame: baseline (IPF diagnosis) and 6 months after baseline
description: vitamin D level in plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: San Gerardo Hospital
investigator full name: Paola Faverio
investigator title: Principal Investigator
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
sharing ipd: No