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

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ClinicalTrials.gov Identifier: NCT03306758
Recruitment Status : Unknown
Verified September 2017 by Jiang lindi, Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jiang lindi, Shanghai Zhongshan Hospital

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE October 11, 2017
Last Update Posted Date October 11, 2017
Estimated Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
Serum uric acid [ Time Frame: 1 month after randomization ]
Change from baseline serum levels of uric acid at 1 month
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
Fraction excretion of uric acid [ Time Frame: 1 month after randomization ]
Change from baseline fraction excretion of uric acid at 1 month
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
Official Title  ICMJE The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asymptomatic Hyperuricemia
  • Gout
Intervention  ICMJE Drug: Sodium Bicarbonate
Sodium Bicarbonate was given 1g tid for one month
Study Arms  ICMJE
  • Experimental: Experimental: sodium bicarbonate
    Intervention: Drug: Sodium Bicarbonate
  • No Intervention: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 5, 2017)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2018
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03306758
Other Study ID Numbers  ICMJE B2017-136R
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiang lindi, Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Zhongshan Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP