<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/NCT02194114</url>
  </required_header>
  <id_info>
    <org_study_id>10602</org_study_id>
    <nct_id>NCT02194114</nct_id>
  </id_info>
  <brief_title>Dietary Protein Requirements in Hemodialysis Patients</brief_title>
  <official_title>Dietary Protein Intake and Its Effect on Nitrogen Balance in Maintenance Hemodialysis (MHD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to assess dietary protein requirements in clinically&#xD;
      stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary&#xD;
      protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a&#xD;
      safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition&#xD;
      (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation&#xD;
      may contribute to PEM, low dietary protein intake (DPI) is often a contributing factor. The&#xD;
      usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend =&#xD;
      1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of&#xD;
      insufficient duration, that were usually carried out with obsolete types of dialysis therapy.&#xD;
&#xD;
      We will examine the response to different levels of dietary protein intake (0.6-1.3 g&#xD;
      protein/kg/day) under classical balance techniques with carefully controlled dietary intakes,&#xD;
      living, conditions, and collection of nitrogen outputs and carefully measured nitrogen&#xD;
      intakes and outputs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2004</start_date>
  <completion_date type="Actual">January 2008</completion_date>
  <primary_completion_date type="Actual">January 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nitrogen Balance</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Chronic Renal Failure</condition>
  <condition>End-Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Dietary Protein Intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One treatment Arm; Protein Diet: All patients will be fed the following five diets, in random order, each for 17-19 days: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein Diet</intervention_name>
    <description>Protein diets fed for 17-19 days to each patient in random order: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.</description>
    <arm_group_label>Dietary Protein Intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages from 30 years through 65 years&#xD;
&#xD;
          -  Both men and women and all ethnic and racial groups&#xD;
&#xD;
          -  Treatment with MHD for 6 months or greater&#xD;
&#xD;
          -  Hemoglobin of at least 11 g/dL&#xD;
&#xD;
          -  Neurological examination indicating no severe neuropathy&#xD;
&#xD;
          -  A negative test for peripheral arterial occlusive disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obesity: body weight greater than &gt;115% of standard&#xD;
&#xD;
          -  History of active cancer other than basal cell carcinoma&#xD;
&#xD;
          -  Symptomatic severe ischemic heart disease, uncontrolled serious dysrhythmias,&#xD;
             uncontrolled congestive heart failure, poorly controlled hypertension, severe&#xD;
             musculoskeletal disease, arthritis or amputations of the lower extremities&#xD;
&#xD;
          -  Insulin dependent or insulin independent diabetes mellitus&#xD;
&#xD;
          -  Severe lung or liver disease, uncontrolled asthma, active vasculitis. Severe chronic&#xD;
             infection or any other acute or chronic inflammatory or catabolic illnesses&#xD;
&#xD;
          -  Psychosis, inability to give informed consent, evidence that patient will not comply&#xD;
             with study protocol&#xD;
&#xD;
          -  Alcohol or other recreational drug abuse&#xD;
&#xD;
          -  Patients who received L-carnitine or anabolic hormones within the previous 6 months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who are physically and/or psychologically incapable of undergoing the&#xD;
             protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel D Kopple, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Renal Failure</keyword>
  <keyword>End-Stage Renal Disease</keyword>
  <keyword>Nitrogen Balance</keyword>
  <keyword>Dietary Protein Intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_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/NCT02194114
org study id: 10602
nct id: NCT02194114
lead sponsor: 
has dmc: Yes
The primary purpose of this study is to assess dietary protein requirements in clinically
      stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary
      protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a
      safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.
A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition
      (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation
      may contribute to PEM, low dietary protein intake (DPI) is often a contributing factor. The
      usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend =
      1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of
      insufficient duration, that were usually carried out with obsolete types of dialysis therapy.

      We will examine the response to different levels of dietary protein intake (0.6-1.3 g
      protein/kg/day) under classical balance techniques with carefully controlled dietary intakes,
      living, conditions, and collection of nitrogen outputs and carefully measured nitrogen
      intakes and outputs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Nitrogen Balance
time frame: One year
arm group label: Dietary Protein Intake
arm group type: Experimental
description: One treatment Arm; Protein Diet: All patients will be fed the following five diets, in random order, each for 17-19 days: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.
intervention type: Other
intervention name: Protein Diet
description: Protein diets fed for 17-19 days to each patient in random order: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.
arm group label: Dietary Protein Intake
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Joel D Kopple, MD
role: Principal Investigator
affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency