<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/NCT03236701</url>
  </required_header>
  <id_info>
    <org_study_id>76/17</org_study_id>
    <nct_id>NCT03236701</nct_id>
  </id_info>
  <brief_title>Egg White for Phosphorus Control in Haemodialysis Patients</brief_title>
  <acronym>UAUDIPE</acronym>
  <official_title>The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</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>
      To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish&#xD;
      included in two meals a week with an amount of egg white containing the same quantity of&#xD;
      proteins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperphosphatemia develops in the majority of patients with end-stage renal disease (ESRD).&#xD;
      It is responsible for severe complications such as mineral bone disease, and has a role in&#xD;
      worsening the cardiovascular mortality of dialyzed patients. Therefore, a close control of&#xD;
      serum phosphorus remains a cornerstone in the clinical management of dialyzed patients to&#xD;
      improve their long term prognosis. There are multiple sources of phosphorus in the diet that&#xD;
      could be the target of such a dietary intervention but, because of important differences in&#xD;
      bioavailability, they are not all equally relevant in influencing phosphatemia. Among them&#xD;
      animal proteins that have a bioavailability of about 60% represent an important target for&#xD;
      phosphate-lowering nutritional interventions. However, lowering the protein content of the&#xD;
      diet in hemodialysis (HD) patients may be dangerous because it may increase the the risk of&#xD;
      malnutrition hence worsening their prognosis. In the present study we intend to explore an&#xD;
      alternative strategy to lower the intake of phosphate with animal proteins by replacing the&#xD;
      meat or fish included in two meals a week with egg white that is reach of proteins but has&#xD;
      virtually no phosphate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in serum phosphate levels</measure>
    <time_frame>Phosphate level will be measured monthly for three months from the beginning of the study</time_frame>
    <description>This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition assessed by bioelectrical impedance analysis</measure>
    <time_frame>BIA will be performed monthly for three months from the beginning of the study</time_frame>
    <description>Protein malnutrition causes a decrease in body cell mass. By bioelectrical impedance analysis (BIA) the changes in this parameter in the two experimental groups will be evaluated at one, two and three months from the beginning of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum albumin concentration</measure>
    <time_frame>Serum albumin will be measured monthly for three months from the beginning of the study</time_frame>
    <description>Protein malnutrition causes a decrease in serum albumin concentration that will be, therefore, monitored, at one, two and three months from the beginning of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hemoglobin levels</measure>
    <time_frame>hemoglobin level will be measured monthly for three months from the beginning of the study</time_frame>
    <description>Protein malnutrition causes a decrease in hemoglobin levels that will be, therefore, monitored, at one, two and three months from the beginning of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Dialysis</condition>
  <condition>Hyperphosphatemia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>egg white instead of meat or fish in two meals twice a week for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Egg White replacement</intervention_name>
    <description>Nutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  thrice weekly 4 h standard bicarbonate HD treatment with an at least 6-month vintage&#xD;
&#xD;
          -  stable dialysis dose and modality at least by 3 months&#xD;
&#xD;
          -  hyperphosphataemia (serum phosphate ≥5.0 mg/dl) at least by 3 months&#xD;
&#xD;
          -  stable dietary intake at least by 3 months&#xD;
&#xD;
          -  stable body weight at least by 3 months&#xD;
&#xD;
          -  stable biochemical markers at least by 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  previous parathyroidectomy&#xD;
&#xD;
          -  psychiatric diseases&#xD;
&#xD;
          -  non-collaborative patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Federico II University Hospital</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Bruna Guida</investigator_full_name>
    <investigator_title>Associate Professor in Physiology</investigator_title>
  </responsible_party>
  <keyword>hyperphosphatemia</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>dietary treatment</keyword>
  <keyword>egg white</keyword>
  <keyword>protein energy wasting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Hyperphosphatemia</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/NCT03236701
org study id: 76/17
nct id: NCT03236701
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish
      included in two meals a week with an amount of egg white containing the same quantity of
      proteins.
Hyperphosphatemia develops in the majority of patients with end-stage renal disease (ESRD).
      It is responsible for severe complications such as mineral bone disease, and has a role in
      worsening the cardiovascular mortality of dialyzed patients. Therefore, a close control of
      serum phosphorus remains a cornerstone in the clinical management of dialyzed patients to
      improve their long term prognosis. There are multiple sources of phosphorus in the diet that
      could be the target of such a dietary intervention but, because of important differences in
      bioavailability, they are not all equally relevant in influencing phosphatemia. Among them
      animal proteins that have a bioavailability of about 60% represent an important target for
      phosphate-lowering nutritional interventions. However, lowering the protein content of the
      diet in hemodialysis (HD) patients may be dangerous because it may increase the the risk of
      malnutrition hence worsening their prognosis. In the present study we intend to explore an
      alternative strategy to lower the intake of phosphate with animal proteins by replacing the
      meat or fish included in two meals a week with egg white that is reach of proteins but has
      virtually no phosphate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Decrease in serum phosphate levels
time frame: Phosphate level will be measured monthly for three months from the beginning of the study
description: This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia
measure: Changes in body composition assessed by bioelectrical impedance analysis
time frame: BIA will be performed monthly for three months from the beginning of the study
description: Protein malnutrition causes a decrease in body cell mass. By bioelectrical impedance analysis (BIA) the changes in this parameter in the two experimental groups will be evaluated at one, two and three months from the beginning of the study.
measure: Changes in serum albumin concentration
time frame: Serum albumin will be measured monthly for three months from the beginning of the study
description: Protein malnutrition causes a decrease in serum albumin concentration that will be, therefore, monitored, at one, two and three months from the beginning of the study.
measure: Changes in hemoglobin levels
time frame: hemoglobin level will be measured monthly for three months from the beginning of the study
description: Protein malnutrition causes a decrease in hemoglobin levels that will be, therefore, monitored, at one, two and three months from the beginning of the study.
arm group label: Control
arm group type: No Intervention
description: usual diet
arm group label: Intervention
arm group type: Experimental
description: egg white instead of meat or fish in two meals twice a week for three months
intervention type: Other
intervention name: Egg White replacement
description: Nutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Bruna Guida
investigator title: Associate Professor in Physiology
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
mesh term: Hyperphosphatemia
sharing ipd: No