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The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout

Primary Purpose

Asymptomatic Hyperuricemia, Gout

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sodium Bicarbonate
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic Hyperuricemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Sign informed consent form;
  2. Serum uric acid ≥420mmol/L;
  3. Within the age range of 18-65 years old;
  4. Within the BMI range of 18-30kg/m2;
  5. Both men and women are eligible

Exclusion Criteria:

  1. General situations

    • Pregnancy or lactation；
    • Participants who can't take contraception during the study or within one month after the completion of the intervention;
    • Situations which will harm the participants;
    • Participants with bad compliance.
  2. Taking part in another trail
  3. Gout flares happening over the last one month;
  4. Administration of medications over the last one month, including: allopurinol, Febuxostat,benzbromarone, and/or sodium bicarbonate；
  5. urine pH>7.0;
  6. Hepatic function：ALT and/or AST and/or TB>1.5 upper limit of normal (ULN);
  7. Renal function：eGFR<60 ml/min for MDRD and/or urine protein>0.5g/24h；
  8. Hypertension：>140/90mmHg;
  9. Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes);
  10. Urinary stone,urinary infection;
  11. Taking drugs ove the last one month and during the trial, including：thiazide diuretic, Loop diuretics, pyrazinamide,ethambutol, tacrolimus, niacin, aspirin, estrogen, losartan, amlodipine, reserpine, vitamin C，fenofibrate，atorvastatin， sulfonylureas，biguanides，NSAIDs;
  12. Disease which influence serum uric acid, such as cancer, lymphoma, and etc.
  13. Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc;
  14. Blood donation or excessive loss of blood over the last 3 month.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental: sodium bicarbonate

    No Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Serum uric acid
    Change from baseline serum levels of uric acid at 1 month

    Secondary Outcome Measures

    Fraction excretion of uric acid
    Change from baseline fraction excretion of uric acid at 1 month

    Full Information

    First Posted
    September 27, 2017
    Last Updated
    October 5, 2017
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03306758
    Brief Title
    The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
    Official Title
    The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2017 (Anticipated)
    Primary Completion Date
    July 31, 2018 (Anticipated)
    Study Completion Date
    September 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Zhongshan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asymptomatic Hyperuricemia, Gout

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: sodium bicarbonate
    Arm Type
    Experimental
    Arm Title
    No Intervention
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Bicarbonate
    Intervention Description
    Sodium Bicarbonate was given 1g tid for one month
    Primary Outcome Measure Information:
    Title
    Serum uric acid
    Description
    Change from baseline serum levels of uric acid at 1 month
    Time Frame
    1 month after randomization
    Secondary Outcome Measure Information:
    Title
    Fraction excretion of uric acid
    Description
    Change from baseline fraction excretion of uric acid at 1 month
    Time Frame
    1 month after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign informed consent form; Serum uric acid ≥420mmol/L; Within the age range of 18-65 years old; Within the BMI range of 18-30kg/m2; Both men and women are eligible Exclusion Criteria: General situations Pregnancy or lactation； Participants who can't take contraception during the study or within one month after the completion of the intervention; Situations which will harm the participants; Participants with bad compliance. Taking part in another trail Gout flares happening over the last one month; Administration of medications over the last one month, including: allopurinol, Febuxostat,benzbromarone, and/or sodium bicarbonate； urine pH>7.0; Hepatic function：ALT and/or AST and/or TB>1.5 upper limit of normal (ULN); Renal function：eGFR<60 ml/min for MDRD and/or urine protein>0.5g/24h； Hypertension：>140/90mmHg; Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes); Urinary stone,urinary infection; Taking drugs ove the last one month and during the trial, including：thiazide diuretic, Loop diuretics, pyrazinamide,ethambutol, tacrolimus, niacin, aspirin, estrogen, losartan, amlodipine, reserpine, vitamin C，fenofibrate，atorvastatin， sulfonylureas，biguanides，NSAIDs; Disease which influence serum uric acid, such as cancer, lymphoma, and etc. Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc; Blood donation or excessive loss of blood over the last 3 month.

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout

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