<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/NCT04489472</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-19-0382</org_study_id>
    <nct_id>NCT04489472</nct_id>
  </id_info>
  <brief_title>The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.</brief_title>
  <official_title>The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of a dietary supplement rich in nitric&#xD;
      oxide (NO) on nasal nitric oxide and fractional exhaled nitric oxide (FeNO),on ciliary beat&#xD;
      frequency assessed by high-speed digital video microscopy and on lung function assessed by&#xD;
      spirometry in normal patients and patients with Primary ciliary dyskinesia (PCD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nasal NO as measured by a chemiluminescence analyzer</measure>
    <time_frame>Baseline,after beet juice consumption(1 hour after consumption)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in nasal NO as measured by a chemiluminescence analyzer</measure>
    <time_frame>Baseline,after beet juice consumption( 2 hours after consumption)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor</measure>
    <time_frame>Baseline,after beet juice consumption(1 hour after consumption)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor</measure>
    <time_frame>Baseline,after beet juice consumption(2 hours after consumption)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM)</measure>
    <time_frame>after beet juice consumption(2 hours after consumption)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lung function as measured by spirometry</measure>
    <time_frame>Baseline,after beet juice consumption(2 hours after consumption)</time_frame>
    <description>spirometry is used to assess how well your lungs work by measuring how much air you inhale,how much you exhale and how quickly you exhale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Primary Ciliary Dyskinesia</condition>
  <arm_group>
    <arm_group_label>PCD Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beet-it Juice</intervention_name>
    <description>Patients will ingest 1 bottle (70ml) of beet-it juice (98% concentrated beet juice, 2% lemon juice containing 400 mg/6.5 mmol nitrate).</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>PCD Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Experimental group:&#xD;
&#xD;
          -  PCD patients&#xD;
&#xD;
        Control Group:&#xD;
&#xD;
          -  patients with no known chronic lung disease&#xD;
&#xD;
          -  18 years to 99 years&#xD;
&#xD;
        Exclusion Criteria(both PCD patients and control group):&#xD;
&#xD;
          -  any other pulmonary co-morbidities and diseases entities like cystic fibrosis, nasal&#xD;
             sinus surgery, nasal sinus hypoplasia/aplasia, deviated nasal septum, nasal polyps and&#xD;
             with upper respiratory tract infection&#xD;
&#xD;
          -  patients allergic to beet&#xD;
&#xD;
          -  a known prolonged bleeding disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo A Mosquera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ricardo A Mosquera, MD</last_name>
    <phone>(713) 500-5650</phone>
    <email>Ricardo.A.Mosquera@uth.tmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diana Castillo</last_name>
    <phone>(713) 500-5359</phone>
    <email>Diana.J.MartinezCastillo@uth.tmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ricardo A Mosquera, MD</last_name>
      <phone>713-500-5650</phone>
      <email>Ricardo.A.Mosquera@uth.tmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Diana Castillo</last_name>
      <phone>(713) 500-5359</phone>
      <email>Diana.J.MartinezCastillo@uth.tmc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Ricardo A. Mosquera</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Nitric oxide</keyword>
  <keyword>Intranasal nitric oxide</keyword>
  <keyword>Beet juice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciliary Motility Disorders</mesh_term>
    <mesh_term>Dyskinesias</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/NCT04489472
org study id: HSC-MS-19-0382
nct id: NCT04489472
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the effect of a dietary supplement rich in nitric
      oxide (NO) on nasal nitric oxide and fractional exhaled nitric oxide (FeNO),on ciliary beat
      frequency assessed by high-speed digital video microscopy and on lung function assessed by
      spirometry in normal patients and patients with Primary ciliary dyskinesia (PCD).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in nasal NO as measured by a chemiluminescence analyzer
time frame: Baseline,after beet juice consumption(1 hour after consumption)
measure: Change in nasal NO as measured by a chemiluminescence analyzer
time frame: Baseline,after beet juice consumption( 2 hours after consumption)
measure: Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor
time frame: Baseline,after beet juice consumption(1 hour after consumption)
measure: Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor
time frame: Baseline,after beet juice consumption(2 hours after consumption)
measure: Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM)
time frame: after beet juice consumption(2 hours after consumption)
measure: Change in lung function as measured by spirometry
time frame: Baseline,after beet juice consumption(2 hours after consumption)
description: spirometry is used to assess how well your lungs work by measuring how much air you inhale,how much you exhale and how quickly you exhale
arm group label: PCD Group
arm group type: Experimental
arm group label: Control Group
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Beet-it Juice
description: Patients will ingest 1 bottle (70ml) of beet-it juice (98% concentrated beet juice, 2% lemon juice containing 400 mg/6.5 mmol nitrate).
arm group label: Control Group
arm group label: PCD Group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 99 Years
healthy volunteers: No
last name: Ricardo A Mosquera, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Ricardo A Mosquera, MD
phone: (713) 500-5650
email: Ricardo.A.Mosquera@uth.tmc.edu
last name: Diana Castillo
phone: (713) 500-5359
email: Diana.J.MartinezCastillo@uth.tmc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Ricardo A. Mosquera
investigator title: Associate Professor
mesh term: Ciliary Motility Disorders
mesh term: Dyskinesias
sharing ipd: No