<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/NCT03306758</url>
  </required_header>
  <id_info>
    <org_study_id>B2017-136R</org_study_id>
    <nct_id>NCT03306758</nct_id>
  </id_info>
  <brief_title>The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout</brief_title>
  <official_title>The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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>
      This study evaluate the serum uric acid lowering effect of sodium bicarbonate as well as its&#xD;
      safety in patients with asymptomatic hyperuricemia or gout. Half of the participants will&#xD;
      receive sodium bicarbonate only, while the other half receive none.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2018</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>Serum uric acid</measure>
    <time_frame>1 month after randomization</time_frame>
    <description>Change from baseline serum levels of uric acid at 1 month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fraction excretion of uric acid</measure>
    <time_frame>1 month after randomization</time_frame>
    <description>Change from baseline fraction excretion of uric acid at 1 month</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Asymptomatic Hyperuricemia</condition>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>Experimental: sodium bicarbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Bicarbonate</intervention_name>
    <description>Sodium Bicarbonate was given 1g tid for one month</description>
    <arm_group_label>Experimental: sodium bicarbonate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign informed consent form;&#xD;
&#xD;
          2. Serum uric acid ≥420mmol/L;&#xD;
&#xD;
          3. Within the age range of 18-65 years old;&#xD;
&#xD;
          4. Within the BMI range of 18-30kg/m2;&#xD;
&#xD;
          5. Both men and women are eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. General situations&#xD;
&#xD;
               -  Pregnancy or lactation；&#xD;
&#xD;
               -  Participants who can't take contraception during the study or within one month&#xD;
                  after the completion of the intervention;&#xD;
&#xD;
               -  Situations which will harm the participants;&#xD;
&#xD;
               -  Participants with bad compliance.&#xD;
&#xD;
          2. Taking part in another trail&#xD;
&#xD;
          3. Gout flares happening over the last one month;&#xD;
&#xD;
          4. Administration of medications over the last one month, including: allopurinol,&#xD;
             Febuxostat,benzbromarone, and/or sodium bicarbonate；&#xD;
&#xD;
          5. urine pH&gt;7.0;&#xD;
&#xD;
          6. Hepatic function：ALT and/or AST and/or TB&gt;1.5 upper limit of normal (ULN);&#xD;
&#xD;
          7. Renal function：eGFR&lt;60 ml/min for MDRD and/or urine protein&gt;0.5g/24h；&#xD;
&#xD;
          8. Hypertension：&gt;140/90mmHg;&#xD;
&#xD;
          9. Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes);&#xD;
&#xD;
         10. Urinary stone,urinary infection;&#xD;
&#xD;
         11. Taking drugs ove the last one month and during the trial, including：thiazide diuretic,&#xD;
             Loop diuretics, pyrazinamide,ethambutol, tacrolimus, niacin, aspirin, estrogen,&#xD;
             losartan, amlodipine, reserpine, vitamin C，fenofibrate，atorvastatin，&#xD;
             sulfonylureas，biguanides，NSAIDs;&#xD;
&#xD;
         12. Disease which influence serum uric acid, such as cancer, lymphoma, and etc.&#xD;
&#xD;
         13. Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract,&#xD;
             rheumatoid disease, blood, endocrine, infection, and etc;&#xD;
&#xD;
         14. Blood donation or excessive loss of blood over the last 3 month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Jiang lindi</investigator_full_name>
    <investigator_title>Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gout</mesh_term>
    <mesh_term>Hyperuricemia</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/NCT03306758
org study id: B2017-136R
nct id: NCT03306758
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluate the serum uric acid lowering effect of sodium bicarbonate as well as its
      safety in patients with asymptomatic hyperuricemia or gout. Half of the participants will
      receive sodium bicarbonate only, while the other half receive none.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serum uric acid
time frame: 1 month after randomization
description: Change from baseline serum levels of uric acid at 1 month
measure: Fraction excretion of uric acid
time frame: 1 month after randomization
description: Change from baseline fraction excretion of uric acid at 1 month
arm group label: Experimental: sodium bicarbonate
arm group type: Experimental
arm group label: No Intervention
arm group type: No Intervention
intervention type: Drug
intervention name: Sodium Bicarbonate
description: Sodium Bicarbonate was given 1g tid for one month
arm group label: Experimental: sodium bicarbonate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Jiang lindi
investigator title: Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital
mesh term: Gout
mesh term: Hyperuricemia